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Medpor 9429

by Stryker Leibinger

Ref 9429

Medpor 9429 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-07613252088769), cleared under FDA 510(k) K922489 on 2 Sep 1992 and listed in FDA GUDID since 24 Sep 2015 (UDI-DI 07613252088769), active as of 7 Nov 2026. One FDA recall is 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

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K922489

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-07613252088769 Basic UDI-DI 07613252088769UDI-DIDate5 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613252088769 UDI-DI Date24 Sep 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK922489 Date2 Sep 1992DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-07613252088769 registered 5 Nov 2026 Active
  • FDA 510(k) K922489 decided 2 Sep 1992 Active
  • FDA GUDID UDI-DI 07613252088769 listed 24 Sep 2015 Listed

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.

Timeline

4 dated events

  1. Cleared FDA 510(k) K922489
  2. Recall initiated FDA recalls Z-1090-2015
  3. Listed FDA GUDID 07613252088769
  4. Registered EUDAMED B-07613252088769

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  • Withdrawn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
Generic name
Orbital wall/rim prosthesis
Model / Ref / Catalog
9429
Primary DI / UDI-DI
07613252088769
Basic UDI-DI
B-07613252088769
510(k) Number
FDA product code
FWP
EMDN code
P900403 Non-resorbable filling and reconstruction devices
GMDN term
Orbital wall/rim prosthesis
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
Height — 18.0 Millimeter
Length — 43.0 Millimeter

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.

Related devices

Category: Orbital rim prosthesis

Cleared under the same submission (K922489)

and 8 more cleared under K922489

Similar devices in this category

Other devices filed under NON-RESORBABLE FILLING AND RECONSTRUCTION DEVICES.

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)