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TiWedgeTM

FDA UDI

Class II (US FDA UDI)

by Ascension Orthopedics, Inc.

Identity

Trade Name
TiWedgeTM FDA UDI
Generic Name
General external orthopaedic fixation system implantation kit, reusable FDA UDI
Device Name
The Integra Titanium Bone Wedge is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot. This set includes LCL trials and cotton trials to evaluate proper size and fit of the implants. A wedge inserter and tamp are also included for assistance. FDA UDI
Model / Reference
TIWEDGEINSTP FDA UDI
Description
The Integra Titanium Bone Wedge is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot. This set includes LCL trials and cotton trials to evaluate proper size and fit of the implants. A wedge inserter and tamp are also included for assistance. FDA UDI

Identifiers

Primary DI / UDI-DI
10381780237471 FDA UDI
FDA Product Code
HWC FDA UDI
HRS FDA UDI
GMDN Term
General external orthopaedic fixation system implantation kit, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3040 FDA UDI
888.3030 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

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

No

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

TiWedgeTM by Ascension Orthopedics, Inc. — Class II — 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 6e8f497b-11bb-4f0e-bdf7-0b97494e2915 36 fields · synced May 30, 2026