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Odyssey® K0001296

by MicroPort Orthopedics Inc.

Ref K0001296

Odyssey® K0001296 is a device classified as Class IIa in the EU and Class I in the US made by MicroPort Orthopedics Inc., registered in EUDAMED on 4 Nov 2026 (Basic UDI-DI 0192629IIAKP091399LT) and listed in FDA GUDID since 31 Oct 2016 (UDI-DI 00192629060609), active as of 7 Nov 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0192629IIAKP091399LT Basic UDI-DI 00192629060609UDI-DIDate4 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00192629060609 UDI-DI Date31 Oct 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0192629IIAKP091399LT registered 4 Nov 2026 Active
  • FDA GUDID UDI-DI 00192629060609 listed 31 Oct 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00192629060609
  2. Registered EUDAMED 0192629IIAKP091399LT

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Odyssey® Sterile Pin Pack EUDAMED
Odyssey® GUDID
Generic name
Joint prosthesis implantation kit, reusable
Device name
Knee Orthopaedic Implant Instruments, Single-Use - Other
Model / Ref / Catalog
K0001296
Primary DI / UDI-DI
00192629060609 EUDAMED
M684K00012961 GUDID
Basic UDI-DI
0192629IIAKP091399LT
Secondary DI
M684K00012961
FDA product code
LXH
EMDN code
P091399 Orthopaedic implant instruments, single-use - other
GMDN term
Joint prosthesis implantation kit, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
888.4540
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00192629060609
GUDID
M684K00012961
Device classEUDAMED
Class IIa
GUDID
Class I

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00192629060609; FDA GUDID lists M684K00012961), so their flags are not compared. Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Joint prosthesis implantation kit, reusable

Similar devices in this category

Other devices filed under ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER.

Other devices from MicroPort Orthopedics Inc.

See all devices from MicroPort Orthopedics Inc. →

Properties

  • Supplied sterile
  • Single use
  • Reusable
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (19, all answered No)