Integra® First Choice®

FDA UDI

Class II (US FDA UDI)

by Ascension Orthopedics, Inc.

Identity

Trade Name: Integra® First Choice® FDA UDI
Generic Name: General external orthopaedic fixation system implantation kit, reusable FDA UDI
Device Name: The Integra First Choice DRUJ System is intended for replacement of the distal radio-ulnar joint for rheumatoid, degenerative, or post traumatic arthritis. The set includes head and stem trials to evaluate the size and fit of the appropriate implant. Instruments are also included to assist with the trials. FDA UDI
Model / Reference: FRSTDRUJINSP FDA UDI
Description: The Integra First Choice DRUJ System is intended for replacement of the distal radio-ulnar joint for rheumatoid, degenerative, or post traumatic arthritis. The set includes head and stem trials to evaluate the size and fit of the appropriate implant. Instruments are also included to assist with the trials. FDA UDI

Identifiers

Primary DI / UDI-DI: 10381780234951 FDA UDI
510(k) Number: K112481 FDA UDI
FDA Product Code: KXE FDA UDI
GMDN Term: General external orthopaedic fixation system implantation kit, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3810 FDA UDI
Commercial Distribution: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

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

Cleared under the same submission

K112481 also covers:

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 4f3bc9a3-f0f1-437b-b334-09577b63ad6c 37 fields · synced May 31, 2026