Incompass Total Ankle System

FDA UDI

Class II (US FDA UDI)

by Wright Medical Technology, Inc.

Identity

Trade Name: Incompass Total Ankle System FDA UDI
Generic Name: Osteotomy guide, reusable FDA UDI
Device Name: Anterior Talar Finish Guide FDA UDI
Model / Reference: 33820135 FDA UDI
Description: Anterior Talar Finish Guide FDA UDI

Identifiers

Catalog Number: 33820135 FDA UDI
Primary DI / UDI-DI: 00889797111768 FDA UDI
FDA Product Code: HSN FDA UDI
GMDN Term: Osteotomy guide, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3110 FDA UDI
Commercial Distribution: 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

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Osteotomy guide, reusable

Incompass Total Ankle System by Wright Medical Technology, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Osteotomy guide, reusable.

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QUANTUM — IN2BONES · Class I
Cut Guide — TREACE MEDICAL CONCEPTS, INC. · Class I
UKNEE™ — UNITED ORTHOPEDIC CORP. · Class I

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: Wright Medical Technology, Inc.

Sources (1)

FDA UDI 2a39138c-8384-4490-9177-796653331e6c 36 fields · synced Jun 8, 2026