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Omnipore Surgical Implants and Accessories

by Matrix Surgical USA

510(k) K123908

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK123908 Date31 Jul 2013ClearedStatusActive

Recalls

3 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-1224-2019 FDA Class II initiated 30 Jan 2019
    • Terminated Z-1223-2019 FDA Class II initiated 30 Jan 2019

    Product mislabeling.

    • Terminated Z-1382-2017 FDA Class II initiated 25 Jan 2017

    Mislabeling. The packaging labeled as left mandible contained a right mandible.

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  • Withdrawn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