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Medpor Surg Implant Material:prefor Cran/Fac Impla

by Porex Technologies Corp.

510(k) K922489

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 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK922489 Date2 Sep 1992ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1090-2015 FDA Class II initiated 17 Dec 2014

    Potential for implant damage, implant cracking off/breaking intra-operatively.

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  • Withdrawn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
FWP
Device Class
Class II
Regulation
21 CFR Part 878.3550
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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