Skip to content

Na 6815-15-205

by Zimmer, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

2 closed

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 Number00889024262195 UDI-DI Date17 Sep 2015ListedStatusListed GUDID: in commercial distribution

Recalls

2 recalls · FDA

    • Terminated Z-2092-2023 FDA Class II initiated 19 May 2023

    Device outer packaging was incorrectly labeled.

    • Terminated Z-0321-2020 FDA Class II initiated 10 Oct 2019

    Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Knee femur stem prosthesis
Model / Ref / Catalog
6815-15-205
Primary DI / UDI-DI
00889024262195
510(k) Number
FDA Product Code
JWH
GMDN Term
Knee femur stem prosthesis
Device Class
Class II
Regulation Number
888.3560
GUDID distribution status
In Commercial Distribution

Related devices

Category: Knee femur stem prosthesis

Cleared under the same submission (K173057)

Show all (12)

Cleared under the same submission (K982903)

Show all (11)

Other devices from Zimmer, Inc.

See all devices from Zimmer, Inc. →

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