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Arthrosurface Toemotion

by Arthrosurface, Inc.

510(k) K132496

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 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 NumberK132496 Date26 Feb 2014ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0475-2016 FDA Class II initiated 9 Jun 2014

    An oversight in the implementation of the design change record resulted in outdated components being shipped to customers. The component did not pass a half-cycle sterilization.

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  • Withdrawn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
LZJ
Device Class
U
Advisory Committee
Unknown
FDA Decision
SESE Substantially Equivalent

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