Sternalock 360 System 74-1192: CE/MDD Class I

Regulatory status

as of registry sync 7 Nov 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDD EUDAMED	NumberB-00841036275266 Basic UDI-DI 00841036275266UDI-DI	Date23 Oct 2026Registered	StatusActive
United States	GUDID listing GUDID	Number00841036275266 UDI-DI	Date22 Nov 2019Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special	NumberK161896	Date2 Aug 2016Decided	StatusActive
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK151019	Date3 Nov 2015Decided	StatusActive

Official records

EUDAMED public site Basic UDI-DI B-00841036275266 — open Devices and search for it
AccessGUDID record UDI-DI 00841036275266
FDA 510(k) database 510(k) number K161896
FDA 510(k) database 510(k) number K151019

Across registries

3 registries list this device

EUDAMED Basic UDI-DI B-00841036275266 registered 23 Oct 2026 Active
FDA 510(k) K161896 decided 2 Aug 2016 Active· +1 more in the status table
FDA GUDID UDI-DI 00841036275266 listed 22 Nov 2019 Listed

Timeline

4 dated events

3 Nov 2015 Cleared FDA 510(k) K151019
2 Aug 2016 Cleared FDA 510(k) K161896
22 Nov 2019 Listed FDA GUDID 00841036275266
23 Oct 2026 Registered EUDAMED B-00841036275266

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Withdrawn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: Sternalock 360 System
Generic name: Needle guide, reusable
Device name: The Sternalock 360 Sternal CLosure System
Model / Ref / Catalog: 74-1192

Primary DI / UDI-DI: 00841036275266
Basic UDI-DI: B-00841036275266
510(k) Number: K151019
K161896
FDA product code: HRS
EMDN code: L091001 Instruments for insertion and extraction of materials for osteosynthesis, reusable
GMDN term: Needle guide, reusable

Device class: Class I EUDAMED
Class II GUDID
Regulation number: 888.3030
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 I	GUDID Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.