Skip to content

Endo-Model Standard Knee Prosthesis System 99-0027/14

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 Number04026575253623 UDI-DI Date1 Nov 2015ListedStatusListed 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  • Withdrawn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
Endo-Model Standard Knee Prosthesis System
Generic Name
Uncoated knee tibia prosthesis, polyethylene
Model / Ref / Catalog
99-0027/14
Primary DI / UDI-DI
04026575253623
510(k) Number
FDA Product Code
KRO
GMDN Term
Uncoated knee tibia prosthesis, polyethylene
Device Class
Class II
Regulation Number
888.3510
GUDID distribution status
In Commercial Distribution

Related devices

Category: Uncoated knee tibia prosthesis, polyethylene

Cleared under the same submission (K821476)

Show all (12)

Other devices from WALDEMAR LINK GmbH & Co. KG

See all devices from WALDEMAR LINK GmbH & Co. KG →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch 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
  • Serial Number: No
  • Manufacturing Date: No