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Accelerating MedTech — Read the Press Release

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EXALTA | Accelerating MedTech

Integrated MedTech OEM Partner

Your global Speed-to-Market enabler

Accelerating the path from design through market clearance, to full-scale commercial launch.

FDA Registered ISO 13485 Integrated MedTech Partner
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FDA Registered ISO 13485 Integrated MedTech Partner EU MDR Certified
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Trusted by Leading MedTech Companies

DePuy Synthes Zimmer Biomet Stryker Arthrex Globus Medical Medtronic VB Spine Enovis SpineArt Alphatec Spine Orthofix Smith & Nephew Treace Medical Skeletal Conmed
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700K+Sq Ft Manufacturing
150+FDA Clearances
10Global Facilities
1,500+Team Members
40%Faster Time-to-Market
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The EXALTA Way (Numbered Rows)

Traditional CMOs manufacture. EXALTA co-develops.

Speed. Agility. Scale. In One Partner.

We integrate design, engineering, regulatory, manufacturing, and post-market surveillance inside a single operating model.

01

Co-Creation, Not Contracting

Access patented, regulatory-cleared technology bricks and platforms spanning Spine, Extremities, Trauma, Recon, and Cardiothoracic.

02

Global Scale, Local Compliance

Certified legal manufacturer with established QMS infrastructure eliminates setup delays.

03

Speed Without Compromise

DFM optimization reduces production costs and time-to-market by up to 40%.

Intent Router

How can we help you today?

Capability Matrix (Process Chart)

Our Operating Model

Concept to Commercialization

One partner from the whiteboard stage through regulatory strategy, manufacturing, and launch.

Co-Create
Whiteboard to concept
Design
Engineering & platforms
Regulate
Clearance strategy
Build
DFM & production
Launch
Market entry
Scale
Growth & supply
Integrated OEMTurnkey systems
Concept to Commercialization
ManufacturingPrecision at scale
Precision Components at Scale
Clinical inputs, VOC, feasibility
Technology bricks, platforms, IP
510(k), CE-MDR, technical files
Process dev, tooling, validation
Commercialization, market access
Volume production, post-market
Integrated OEM Solutions
Manufacturing Solutions
Solutions Grid (3-Path)

From Platform to Scale

Innovation Pipeline and Capabilities

From proven implant systems and procedure solutions to global-scale industrialization, EXALTA helps you launch faster and scale with quality.

Markets Served

Where EXALTA helps OEMs win.

Orthopedics and adjacent segments supported globally.

Trauma Spine Extremities Enabling Tech
See markets served

Innovation Platforms

Proven foundations to launch faster.

Close portfolio gaps faster and accelerate market clearance using proven implant systems and procedure solutions.

Plating Cabling Screws
Explore Innovation Pipeline

Capabilities

From industrialization to global scale.

Global-scale manufacturing for mission-critical products, built to perform.

DFM Manufacturing Quality Sites
View capabilities
Solutions Toggle

Your End-to-End Integrated Partner for Program Acceleration

Collaborative DFM, material selection, and tolerance optimization from day one.

Design-for-manufacturing optimization reduces costs by up to 40%

Material selection and tolerance analysis built into every engagement

Patented technology bricks spanning Spine, Extremities, Trauma, Recon, and Cardiothoracic

Markets
Market Cards

Clinical Markets

Markets We Serve

Spine

CNC-machined titanium and cobalt-chrome spinal implants with surface texturing for osseointegration.

Robotics & Navigation

Surgical robotics platforms and computer-assisted navigation systems for next-generation precision.

Growth

Trauma

Titanium trauma implant systems with modular fixation options for acute and complex fracture cases.

Lower Extremities

Precision plating, screws, and instrumentation for lower-extremity fracture repair and reconstruction.

Upper Extremities

Shoulder, elbow, and wrist implant systems with precision-machined components and validated instrumentation.

Markets Carousel
Footprint Grid

Global Facilities

Across 3 Continents

Nearshoring, supply chain resilience, and rapid program execution.

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Ready to Accelerate?

From first conversation to first article — we compress the timeline so you reach market faster.

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Manufacturing Excellence

Manufacturing Excellence

ISO 13485-certified production with CNC, injection molding, additive manufacturing, and clean room assembly.

Global Reach

Global Presence

10 facilities across 3 continents delivering consistent quality, nearshoring flexibility, and supply chain resilience.

Precision Engineering

Engineering Innovation

Collaborative DFM, rapid prototyping, and regulatory expertise to compress your path from concept to patient.

Client Canonical
Who We Are (Split Layout)

Because you need more than a product.

Who We Are

Turning fragmented supply chains into launch-ready results.

Your integrated partner across development, manufacturing, and lifecycle support.

EXALTA meets you where you are, from components to complete systems. By connecting development, industrialization, and manufacturing under one roof, we reduce friction between phases and support market clearance and scalable production.

What We Do (Two-Column)

What We Do

Two Paths. One Integrated Partner.

Integrated OEM Solutions

Concept to market clearance for portfolio gap wins.

Integrated OEM Solutions is where EXALTA partners to build market-ready systems that help OEMs close portfolio gaps, whether you are recapturing share or penetrating new markets. We align requirements, design, verification, and clearance readiness into one coordinated path, so programs move faster with fewer surprises across the MedTech spectrum.

  • End-to-end system development with OEM partnership
  • Access to market-cleared systems with proven regulatory know-how
  • Lifecycle support from launch through steady-state production
Explore Integrated OEM Solutions

Manufacturing Solutions

Global scale with uncompromising quality.

Manufacturing Solutions is how EXALTA industrializes and produces with consistency at scale. With a global footprint and strong engineering support, we deliver design-for-manufacturability, clean product transfer, and repeatable production for instruments, implants, trays, and mission-critical components for enabling technologies.

  • Global manufacturing footprint built for scale and continuity
  • Engineering depth for DFM, process development, and product transfer
  • Uncompromising quality systems and process control
Explore Manufacturing Solutions
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Ready to elevate your next program?

Tell us where you are in the journey. We'll map the fastest path to success.

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Explore EXALTA

Markets Served

Where EXALTA helps OEMs win.

Orthopedics and adjacent segments supported globally.

Trauma Spine Extremities Enabling Tech
See Markets Served

Innovation Pipeline

Proven foundations to launch faster.

Close portfolio gaps faster and accelerate market clearance using proven implant systems and procedure solutions.

Plating Cabling Screws
Explore Innovation Pipeline

Capabilities

From industrialization to global scale.

Global-scale manufacturing for mission-critical products, built to perform.

DFM Manufacturing Quality Sites
View Capabilities
EXALTA by the Numbers

EXALTA by the Numbers

Built to deliver
at scale

Global Presence

Across 3 Continents
Nearshoring, supply chain resilience, and rapid program execution.

150+

510(k) clearances achieved

As manufacturer of record

30+

Global registrations owned

EU MDR · MDSAP · UKCA

55+

R&D Engineers

250+

Patents Issued

100+

End-to-End Launches

Contact Page
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Contact EXALTA

Talk With EXALTA

Tell us what you are building. An EXALTA specialist will reply within one business day.

Contact Form

Send EXALTA a Message

Share your needs and we will connect you with the right EXALTA team.

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Headquarters

Memphis, TN
United States

Global Presence

10 facilities across 3 continents

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Numbered Value Props

Why EXALTA

Speed. Agility. Scale.
In One Partner.

We integrate design, engineering, regulatory, manufacturing, and post-market surveillance inside a single operating model.

01

Co-Creation, Not Contracting

Access patented, regulatory-cleared technology platforms spanning Spine, Extremities, Trauma, Recon, and Cardiothoracic. Co-develop differentiated products to rapidly fill portfolio gaps.

02

Global Scale, Local Compliance

Certified legal manufacturer with established QMS infrastructure. Turnkey 510(k) and EU MDR-cleared systems across a global manufacturing footprint with nearshoring options.

03

Speed Without Compromise

DFM optimization reduces production costs and time-to-market by up to 40%. Strategic inventory and flexible supply chain from prototype to high-volume manufacturing.

Showcase Cards 3-Up

Explore

Technologies, Markets,
and Capabilities

Technologies

The technology you need to enhance your product line.

Explore

Markets

Rapidly influencing a variety of markets.

Orthopedic | Spine | Trauma | Extremities

Explore

Capabilities

Everything you need, start to finish.

Design | Manufacture | Quality

Explore
The EXALTA Way — Tabbed

Our Operating Model

The EXALTA Way

Four phases of device commercialization. Each staffed with dedicated resources, not shared capacity borrowed from other engagements.

Design

Aligns clinical need, design inputs, and manufacturability from day one.

Marketing — Voice of Customer | Design Inputs | Validation Labs
R&D — Product Design | DFM | Design Input Translation | Testing

Marketing

VOC, Inputs, Validation Labs

R&D

Design, DFM, Testing

Develop

Engineering transforms validated designs into production-ready specifications with full regulatory documentation.

Engineering — Process Development | Tooling Design | Fixture Engineering
Regulatory — 510(k) Submissions | Technical Files | EU MDR Compliance
Quality — Design Verification | Risk Management | DHF Documentation

Engineering

Process Dev, Tooling, Fixtures

Regulatory

510(k), EU MDR, Technical Files

Quality

V&V, Risk, DHF

Manufacture

Production scales from first article through high-volume manufacturing across 12 global facilities.

Operations — CNC Machining | Forging | 3D Printing | Surface Treatment
Supply Chain — Raw Material Sourcing | Strategic Inventory | Nearshoring
Quality — In-Process Inspection | Final Release | Lot Traceability

Operations

CNC, Forging, Additive, Surface

Supply Chain

Sourcing, Inventory, Nearshoring

Quality

Inspection, Release, Traceability

Maintain

Post-market surveillance and continuous improvement throughout the product lifecycle.

Post-Market — Complaint Handling | CAPA | Field Safety Corrective Actions
Regulatory — Annual Reports | Renewal Submissions | Market Expansion Filings

Post-Market

Complaints, CAPA, FSCA

Regulatory

Reports, Renewals, Expansion

Case Study
Cover (Case Study Header)
Case Study · Anterior Cervical Platform
Speed to Revenue.
How a Fortune 500 orthopedic OEM leveraged the EXALTA Integrated Platform to take an anterior cervical system from Voice of Customer to product launch in 24 months.
Meta Grid (Case Study Metadata)
Customer
Fortune 500 OEM · Orthopedic Division
Product Category
Cervical Spine Implant System
Timeline
VOC to Launch · 24 Months
Markets
US → EU → APAC
EXALTA Model
Integrated Platform
Value Chain Grid
The EXALTA Platform
Design. Develop. Manufacture. Maintain.
Design
Marketing
Voice of Customer
Design Inputs
R&D
Product Design
Design for Mfg
Develop
Manufacturing
Supply Chain
Design Transfer
Regulatory
Market Authorizations
Labeling
Manufacture
Operations
On-Site Manufacturing
Class 7 Clean Room
Quality
Risk Management
Post-Market
Maintain
Clinical
Post-Market Follow-up
Clinical Reports
Regulatory
Change Assessments
Renewal Filings
Execution Flow Row
Execution Model
How EXALTA Delivers
Stage 01
R&D & Marketing
Stage 02
Operations & Manufacturing
Stage 03
Regulatory & Clinical
Stage 04
Integrated Platform
Outcome
Speed to Revenue
CEO Quote Block
CE
CEO Perspective
"The EXALTA platform exists to solve one problem: the gap between what OEMs need and what traditional CDMOs deliver. We don't just manufacture, we co-develop, we hold the DHF, and we stay accountable from first design input through post-market."
Christopher Elkins · CEO, EXALTA Group
Callout / Pull Quote
"The need to launch an innovative product with speed was critical to the cervical portfolio transformation."
Customer A