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MobileLink Acetabular Cup System - Instruments 183-131/06

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 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 Number04026575433377 UDI-DI Date27 Apr 2023ListedStatusListed GUDID: in commercial distribution

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0728-2019 FDA Class II initiated 4 Dec 2018
    • Terminated Z-0729-2019 FDA Class II initiated 4 Dec 2018

    The internal labeling included with these implants may include incorrect part numbers and could result in these incorrect labels being added to patient records.

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  • Withdrawn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
Surgical instrument handle, non-torque-limiting
Model / Reference
183-131/06
Primary DI / UDI-DI
04026575433377
510(k) Number
FDA Product Code
MEH, LZO
GMDN Term
Surgical instrument handle, non-torque-limiting
Device Class
Class II
Regulation Number
888.3353
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

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