Skip to content

Allure Hip Stem 296-003/12

by WALDEMAR LINK GmbH & Co. KG GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04026575447688 UDI-DIDate21 Nov 2025ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

GUDID

Trade Name
Allure Hip Stem
Generic Name
Coated hip femur prosthesis, modular
Model / Reference
296-003/12
Primary DI / UDI-DI
04026575447688
510(k) Number
FDA Product Code
KWY, LPH, LZO, OQG, MEH
GMDN Term
Coated hip femur prosthesis, modular
Device Class
Class II
Regulation Number
888.3390, 888.3358, 888.3353
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K250375)

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
  • 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