Integra® External Fixation System

FDA UDI

Class II (US FDA UDI)

by Ascension Orthopedics, Inc.

Identity

Trade Name: Integra® External Fixation System FDA UDI
Generic Name: External orthopaedic fixation system, reusable FDA UDI
Device Name: The Integra External Fixation System 5/8 ring is used for stability and structure. It is manufactured from aluminum. It is intended for the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of external fixation. FDA UDI
Model / Reference: 12224111 FDA UDI
Description: The Integra External Fixation System 5/8 ring is used for stability and structure. It is manufactured from aluminum. It is intended for the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of external fixation. FDA UDI

Identifiers

Catalog Number: 12224111 FDA UDI
Primary DI / UDI-DI: 10381780125587 FDA UDI
510(k) Number: K140463 FDA UDI
FDA Product Code: KTT FDA UDI
GMDN Term: External orthopaedic fixation system, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3030 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

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Implantable

Yes

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Contains Latex

FDA UDI

Prescription Use

Yes

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Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

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Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

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Serial Number

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Expiration Date

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Manufacturing Date

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Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: External orthopaedic fixation system, reusable

The Integra External Fixation System is a customizable, reusable orthopedic external fixation system designed to promote healing and stabilize fractured bones. It's intended for various bone conditions, including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other non-vertebral bone conditions.

Similar devices

Also classified as External orthopaedic fixation system, reusable.

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TransFx™ — Zimmer, Inc. · Class I
HOFFMANN — Stryker Corp. · Class II
SIDEKICK — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II
TENXOR — Stryker Corp. · Class II

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Ascension Orthopedics, Inc.

Sources (1)

FDA UDI 15362bf5-529d-4fcd-a27f-fc158bf7982d 38 fields · synced Aug 1, 2026