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OmniPore

by Matrix Surgical Holdings, LLC dba Matrix Surgical USA 73 variants

Ref OP9312

OmniPore (OP9312) is a medical device (EU MDD Class IIb; FDA Class II; FDA product code KKY; EMDN category implantable prosthetic devices) made by Matrix Surgical Holdings, LLC dba Matrix Surgical USA, registered in EUDAMED on 22 Apr 2026 (Basic UDI-DI B-00855421005079), cleared under FDA 510(k) K123908 on 31 Jul 2013 and listed in FDA GUDID since 21 Apr 2020 (UDI-DI 00855421005079), active as of 22 Oct 2026. 3 FDA recalls are linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

3 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K123908

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00855421005079 Basic UDI-DI 00855421005079UDI-DIDate22 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00855421005079 UDI-DI Date21 Apr 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK123908 Date31 Jul 2013DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00855421005079 registered 22 Apr 2026 Active
  • FDA 510(k) K123908 decided 31 Jul 2013 Active
  • FDA GUDID UDI-DI 00855421005079 listed 21 Apr 2020 Listed

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.

Timeline

6 dated events

  1. Cleared FDA 510(k) K123908
  2. Recall initiated FDA recalls Z-1382-2017
  3. Recall initiated FDA recalls Z-1224-2019
  4. Recall initiated FDA recalls Z-1223-2019
  5. Listed FDA GUDID 00855421005079
  6. Registered EUDAMED B-00855421005079

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
OmniPore EUDAMED
OmniPore Surgical Implant GUDID
Generic name
Polyethylene craniofacial tissue reconstructive material
Model / reference
OP9312
Primary DI / UDI-DI
00855421005079
Basic UDI-DI
B-00855421005079
510(k) Number
FDA product code
KKY
EMDN code
P9099 Implantable prosthetic devices - other
GMDN term
Polyethylene craniofacial tissue reconstructive material
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.3500
EU registration type
Legacy device (under a directive)
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution
Sterilisation method
Ethylene Oxide

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
US-MF-000018643
Authorised representative
MedEnvoy Global BV NL-AR-000024028

Similar devices in this category

Other devices filed under IMPLANTABLE PROSTHETIC AND OSTEOSYNTHESIS DEVICES - VARIOUS.

Other devices from Matrix Surgical Holdings, LLC dba Matrix Surgical USA

See all devices from Matrix Surgical Holdings, LLC dba Matrix Surgical USA →

Properties

  • Supplied sterile
  • Sterilise before use
  • Single use
  • Implantable
Other properties (19, all answered No)