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MobileLink Acetabular Cup System - Instruments 183-168/01

by WALDEMAR LINK GmbH & Co. KG

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 ongoing

This device is named in the recall

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 Number04026575192373 UDI-DI Date27 Apr 2023ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2641-2023 FDA Class II initiated 14 Jul 2023

    Product is labeled with incorrect offset.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
MobileLink Acetabular Cup System - Instruments
Generic Name
Orthopaedic implant impactor, reusable
Model / Reference
183-168/01
Primary DI / UDI-DI
04026575192373
510(k) Number
FDA Product Code
LPH, OQG
GMDN Term
Orthopaedic implant impactor, reusable
Device Class
Class II
Regulation Number
888.3358
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic implant impactor, reusable

Cleared under the same submission (K200607)

Show all (12)

Other devices from WALDEMAR LINK GmbH & Co. KG

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Properties

  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (11)

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