Skip to content

Medpor Barrier 9312

by Stryker Leibinger

Ref 9312

Medpor Barrier 9312 is a device classified as Class IIb in the EU and Class II in the US made by Stryker Leibinger, registered in EUDAMED on 5 Nov 2026 (Basic UDI-DI B-07613252085805), cleared under FDA 510(k) K952677 on 21 Aug 1995 and listed in FDA GUDID since 24 Sep 2015 (UDI-DI 07613252085805), active as of 7 Nov 2026. 2 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

2 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K952677

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-07613252085805 Basic UDI-DI 07613252085805UDI-DIDate5 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613252085805 UDI-DI Date24 Sep 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK952677 Date21 Aug 1995DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-07613252085805 registered 5 Nov 2026 Active
  • FDA 510(k) K952677 decided 21 Aug 1995 Active
  • FDA GUDID UDI-DI 07613252085805 listed 24 Sep 2015 Listed

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-1092-2015 FDA Class II initiated 17 Dec 2014
    • Terminated Z-1091-2015 FDA Class II initiated 17 Dec 2014

    Potential for implant deformation, implant mechanical stability too low, loss of barrier adhesion intra-operatively, implant damage, implant cracking off/breaking intra-operatively.

Timeline

5 dated events

  1. Cleared FDA 510(k) K952677
  2. Recall initiated FDA recalls Z-1092-2015
  3. Recall initiated FDA recalls Z-1091-2015
  4. Listed FDA GUDID 07613252085805
  5. Registered EUDAMED B-07613252085805

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  • Withdrawn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
Medpor Barrier
Generic name
Polyethylene craniofacial tissue reconstructive material
Model / Ref / Catalog
9312
Primary DI / UDI-DI
07613252085805
Basic UDI-DI
B-07613252085805
510(k) Number
FDA product code
FWP
EMDN code
P900403 Non-resorbable filling and reconstruction devices
GMDN term
Polyethylene craniofacial tissue reconstructive material
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.3550
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Size
Width — 50.0 Millimeter
Length — 76.0 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Related devices

Category: Polyethylene craniofacial tissue reconstructive material

Cleared under the same submission (K952677)

and 4 more cleared under K952677

Other devices from Stryker Leibinger

  • 92-55772

    Class II

  • 92-55773

    Class II

  • 92-55771

    Class II

  • 92-55770

    Class II

See all devices from Stryker Leibinger →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)