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Integra®

FDA UDI

Class I (US FDA UDI)

by Ascension Orthopedics, Inc.

Identity

Trade Name
Integra® FDA UDI
Generic Name
External orthopaedic fixation system, reusable FDA UDI
Device Name
Integra® External Fixation System The Maintenance Kit consists of a 10mm and 13mm box wrench, a universal bolt tubular wrench, a pivoting socket wrench, and a k-wire guide. These instruments are used with the Integra External Fixation System. FDA UDI
Model / Reference
1222MAINKIT FDA UDI
Description
Integra® External Fixation System The Maintenance Kit consists of a 10mm and 13mm box wrench, a universal bolt tubular wrench, a pivoting socket wrench, and a k-wire guide. These instruments are used with the Integra External Fixation System. FDA UDI

Identifiers

Catalog Number
1222MAINKIT FDA UDI
Primary DI / UDI-DI
10381780248231 FDA UDI
FDA Product Code
HXC FDA UDI
LXH FDA UDI
GMDN Term
External orthopaedic fixation system, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Integra® by Ascension Orthopedics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ascension Orthopedics, Inc.

Sources (1)

  • FDA UDI 8626591f-a777-4ca8-82a6-361122ded8db 37 fields · synced Jun 1, 2026