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Hard Tissue Replace(Htr(R))-Patient-Match Implant

by Polyclinic Medical Center

510(k) K924935

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 9 Oct 2026. What this means

Regulatory status

as of registry sync 9 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK924935 Date2 Sep 1993ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2751-2016 FDA Class II initiated 13 Jun 2016

    Potential sterility deficiency.

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  • Withdrawn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
KKY
Device Class
Class II
Regulation
21 CFR Part 878.3500
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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