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TiWedge™

FDA UDI

Class II (US FDA UDI)

by Ascension Orthopedics, Inc.

Identity

Trade Name
TiWedge™ FDA UDI
Generic Name
Surgical implant template, reusable FDA UDI
Device Name
The Integra® Titanium Bone WedgeTrials are inserted until the footprint is congruent to the dimensions of the osteotomy surface, and the desired amount of correction is achieved. The trial is to confirm that the implanted wedge will be congruent with the osteotomy surface to provide the most optimal site for ingrowth of bone into the wedge. FDA UDI
Model / Reference
TRL-1006-L03 FDA UDI
Description
The Integra® Titanium Bone WedgeTrials are inserted until the footprint is congruent to the dimensions of the osteotomy surface, and the desired amount of correction is achieved. The trial is to confirm that the implanted wedge will be congruent with the osteotomy surface to provide the most optimal site for ingrowth of bone into the wedge. FDA UDI

Identifiers

Primary DI / UDI-DI
10381780237563 FDA UDI
510(k) Number
K131360 FDA UDI
FDA Product Code
HWC FDA UDI
HRS FDA UDI
GMDN Term
Surgical implant template, 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

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

TiWedge™ 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 3e3dd433-d81e-4402-9c26-e18fc977d629 37 fields · synced Jun 8, 2026