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LINK® BiMobile(TM) Dual Mobility System

by WALDEMAR LINK GmbH & Co. KG

510(k) K171273

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK171273 Date19 Jan 2018ClearedStatusActive

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  • Withdrawn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 — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MEH
Device Class
Class II
Regulation
21 CFR Part 888.3353
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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