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MobileLink Acetabular Cup System 183-862/32

by WALDEMAR LINK GmbH & Co. KG

MobileLink Acetabular Cup System 183-862/32 is a Class II device made by WALDEMAR LINK GmbH & Co. KG, cleared under FDA 510(k) K182321 on 24 May 2019 and listed in FDA GUDID since 9 Sep 2019 (UDI-DI 04026575189786), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K182321

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04026575189786 UDI-DI Date9 Sep 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK182321 Date24 May 2019DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K182321 decided 24 May 2019 Active
  • FDA GUDID UDI-DI 04026575189786 listed 9 Sep 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K182321
  2. Listed FDA GUDID 04026575189786

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
MobileLink Acetabular Cup System
Generic name
Non-constrained polyethylene acetabular liner
Model / Ref / Catalog
183-862/32
Primary DI / UDI-DI
04026575189786
510(k) Number
FDA product code
MEH, LZO, OQG, LPH
GMDN term
Non-constrained polyethylene acetabular liner
Device class
Class II
Regulation number
888.3353, 888.3358
GUDID distribution status
In Commercial Distribution

Other devices from WALDEMAR LINK GmbH & Co. KG

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Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
Other properties (11, all answered No)