Spine Instruments 03.51.10.0881: CE/MDD Class IIa

Regulatory status

as of registry sync 7 Nov 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDD EUDAMED	NumberB-07630971268920 Basic UDI-DI 07630971268920UDI-DI	Date29 Oct 2026Registered	StatusActive
United States	GUDID listing GUDID	Number07630971268920 UDI-DI	Date24 Feb 2021Listed	StatusListed GUDID: in commercial distribution

Official records

EUDAMED public site Basic UDI-DI B-07630971268920 — open Devices and search for it
AccessGUDID record UDI-DI 07630971268920

Across registries

2 registries list this device

EUDAMED Basic UDI-DI B-07630971268920 registered 29 Oct 2026 Active
FDA GUDID UDI-DI 07630971268920 listed 24 Feb 2021 Listed

Timeline

2 dated events

24 Feb 2021 Listed FDA GUDID 07630971268920
29 Oct 2026 Registered EUDAMED B-07630971268920

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDD Active
United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name: MUST MC Modular Tap 2Lead Ø6.5x30 - Sterile (2x) EUDAMED
Spine Instruments GUDID
Generic name: Orthopaedic prosthesis implantation positioning instrument, single-use
Device name: Spine Tap
Model / reference: 03.51.10.0881

Primary DI / UDI-DI: 07630971268920
Basic UDI-DI: B-07630971268920
FDA product code: LXH
EMDN code: P091399 Orthopaedic implant instruments, single-use - other
GMDN term: Orthopaedic prosthesis implantation positioning instrument, single-use

Device class: Class IIa EUDAMED
Class I GUDID
Regulation number: 888.4540
EU registration type: Legacy device (under a directive)
EU market of registration: Italy
GUDID distribution status: In Commercial Distribution

Truth per registry

2 sources · 1 field differs

Field	EUDAMED	GUDID
Device class	EUDAMED Class IIa	GUDID Class I

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.