Bt Loop BTBXL01709: CE/MDD Class IIb, S.B.M

Regulatory status

as of registry sync 7 Nov 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDD EUDAMED	NumberB-03760154008204 Basic UDI-DI 03760154008204UDI-DI	Date4 Nov 2026Registered	StatusActive
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK250844	Date2 Jun 2025Decided	StatusActive
United States	GUDID listing GUDID	Number03760154008204 UDI-DI	Date20 Dec 2023Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special	NumberK202193	Date16 Oct 2020Decided	StatusActive

Official records

EUDAMED public site Basic UDI-DI B-03760154008204 — open Devices and search for it
AccessGUDID record UDI-DI 03760154008204
FDA 510(k) database 510(k) number K250844
FDA 510(k) database 510(k) number K202193

Across registries

3 registries list this device

EUDAMED Basic UDI-DI B-03760154008204 registered 4 Nov 2026 Active
FDA 510(k) K250844 decided 2 Jun 2025 Active· +1 more in the status table
FDA GUDID UDI-DI 03760154008204 listed 20 Dec 2023 Listed

Timeline

4 dated events

16 Oct 2020 Cleared FDA 510(k) K202193
20 Dec 2023 Listed FDA GUDID 03760154008204
2 Jun 2025 Cleared FDA 510(k) K250844
4 Nov 2026 Registered EUDAMED B-03760154008204

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDD Active
United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name: Btloop EUDAMED
Bt Loop GUDID
Generic name: Tendon/ligament bone anchor, non-bioabsorbable
Device name: Adjustable Fixation System for Ligament Reconstruction
Model / Ref / Catalog: Fixation System for ACL Reconstruction (Bone Tendon Bone Transplant), BTBXL01709, Adjustable fixation system for ligament reconstruction-Cortical Tunnel Ø5-10mm

Primary DI / UDI-DI: 03760154008204
Basic UDI-DI: B-03760154008204
510(k) Number: K202193
K250844
FDA product code: MBI
EMDN code: P091299 Osteosynthesis devices, devices for tendon and ligament synthesis - other
GMDN term: Tendon/ligament bone anchor, non-bioabsorbable

Device class: Class IIb EUDAMED
Class II GUDID
Regulation number: 888.3040
EU registration type: Legacy device (under a directive)
EU market of registration: France
GUDID distribution status: In Commercial Distribution

MRI safety: MR Conditional

Truth per registry

2 sources · 2 fields differ

Field	EUDAMED	GUDID
Model / reference	EUDAMED Fixation System for ACL Reconstruction (Bone Tendon Bone Transplant) BTBXL01709	GUDID Adjustable fixation system for ligament reconstruction-Cortical Tunnel Ø5-10mm
Device class	EUDAMED 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.