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Oss(Tm) Rs Universal Tibial Augment RD122161

by Biomet Orthopedics, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00880304649347 UDI-DI Date23 Aug 2021ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Oss(Tm) Rs Universal Tibial Augment
Generic Name
Knee tibia prosthesis trial, reusable
Model / Ref / Catalog
RD122161
Primary DI / UDI-DI
00880304649347
FDA Product Code
HWT
GMDN Term
Knee tibia prosthesis trial, reusable
Device Class
Class I
Regulation Number
888.4800
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Knee tibia prosthesis trial, reusable

Other devices from Biomet Orthopedics, Inc.

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Properties

  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (10)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No