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Gemini SL Total Knee System 318-472/01

by WALDEMAR LINK GmbH & Co. KG

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

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 Number04026575416172 UDI-DI Date25 Jan 2023ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Gemini SL Total Knee System
Generic Name
Uncoated knee tibia prosthesis, metallic
Model / Reference
318-472/01
Primary DI / UDI-DI
04026575416172
510(k) Number
FDA Product Code
JWH
GMDN Term
Uncoated knee tibia prosthesis, metallic
Device Class
Class II
Regulation Number
888.3560
GUDID distribution status
In Commercial Distribution

Related devices

Category: Uncoated knee tibia prosthesis, metallic

Cleared under the same submission (K182872)

Show all (12)

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Serial Number
  • Expiration Date

Other properties (8)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Manufacturing Date: No