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 washer is used in conjunction with the Integra External Fixation System. It is made from stainless steel and is rectangular in shape. FDA UDI
Model / Reference: 12224202 FDA UDI
Description: The washer is used in conjunction with the Integra External Fixation System. It is made from stainless steel and is rectangular in shape. FDA UDI

Identifiers

Catalog Number: 12224202 FDA UDI
Primary DI / UDI-DI: 10381780125099 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

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: External orthopaedic fixation system, reusable

Integra® External Fixation System by Ascension Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 cacce8a7-e10a-4e18-92fb-65c024ea3568 38 fields · synced May 30, 2026