Odyssey® K0001298: CE/MDR Class IIa

Regulatory status

as of registry sync 7 Nov 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR EUDAMED	Number0192629IIAKP091399LT Basic UDI-DI 00192629074071UDI-DI	Date4 Nov 2026Registered	StatusActive
United States	GUDID listing GUDID	Number00192629074071 UDI-DI	Date31 Oct 2016Listed	StatusListed GUDID: in commercial distribution

Official records

EUDAMED public site Basic UDI-DI 0192629IIAKP091399LT — open Devices and search for it

Across registries

2 registries list this device

EUDAMED Basic UDI-DI 0192629IIAKP091399LT registered 4 Nov 2026 Active
FDA GUDID UDI-DI 00192629074071 listed 31 Oct 2016 Listed

Timeline

2 dated events

31 Oct 2016 Listed FDA GUDID 00192629074071
4 Nov 2026 Registered EUDAMED 0192629IIAKP091399LT

Coverage

2 jurisdictions

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Withdrawn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 Aggressive Pins 6 Each EUDAMED
Odyssey® GUDID
Generic name: Joint prosthesis implantation kit, reusable
Device name: Knee Orthopaedic Implant Instruments, Single-Use - Other
Model / Ref / Catalog: K0001298

Primary DI / UDI-DI: 00192629074071 EUDAMED
M684K00012981 GUDID
Basic UDI-DI: 0192629IIAKP091399LT
Secondary DI: M684K00012981
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

Field	EUDAMED	GUDID
Primary DI / UDI-DI	EUDAMED 00192629074071	GUDID M684K00012981
Device class	EUDAMED Class IIa	GUDID Class I

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00192629074071; FDA GUDID lists M684K00012981), 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.