Ribfix Blu System 76-2601: CE/MDD Class IIb

Regulatory status

as of registry sync 7 Nov 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDD EUDAMED	NumberB-00888233001335 Basic UDI-DI 00888233001335UDI-DI	Date24 Oct 2026Registered	StatusActive
United States	GUDID listing GUDID	Number00888233001335 UDI-DI	Date18 Jun 2020Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special	NumberK162974	Date9 Dec 2016Decided	StatusActive
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK152253	Date24 Mar 2016Decided	StatusActive
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK142823	Date25 Feb 2015Decided	StatusActive

Official records

EUDAMED public site Basic UDI-DI B-00888233001335 — open Devices and search for it
AccessGUDID record UDI-DI 00888233001335
FDA 510(k) database 510(k) number K162974
FDA 510(k) database 510(k) number K152253
FDA 510(k) database 510(k) number K142823

Across registries

3 registries list this device

EUDAMED Basic UDI-DI B-00888233001335 registered 24 Oct 2026 Active
FDA 510(k) K162974 decided 9 Dec 2016 Active· +2 more in the status table
FDA GUDID UDI-DI 00888233001335 listed 18 Jun 2020 Listed

Timeline

5 dated events

25 Feb 2015 Cleared FDA 510(k) K142823
24 Mar 2016 Cleared FDA 510(k) K152253
9 Dec 2016 Cleared FDA 510(k) K162974
18 Jun 2020 Listed FDA GUDID 00888233001335
24 Oct 2026 Registered EUDAMED B-00888233001335

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Withdrawn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: Ribfix Blu System
Generic name: Orthopaedic fixation plate, non-bioabsorbable
Model / Ref / Catalog: 76-2601

Primary DI / UDI-DI: 00888233001335
Basic UDI-DI: B-00888233001335
510(k) Number: K142823
K152253
K162974
FDA product code: HRS, HWC
EMDN code: P09120503 Osteosynthesis screw-plate systems
GMDN term: Orthopaedic fixation plate, non-bioabsorbable

Device class: Class IIb EUDAMED
Class II GUDID
Regulation number: 888.3030, 888.3040
EU registration type: Legacy device (under a directive)
EU market of registration: Netherlands
GUDID distribution status: In Commercial Distribution

Sterilisation method: Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

Field	EUDAMED	GUDID
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.