Zina 61112750: CE/MDD Class IIb

Regulatory status

as of registry sync 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDD EUDAMED	NumberB-06942674655879 Basic UDI-DI 06942674655879UDI-DI	Date24 Jun 2022Registered	StatusActive
United States	FDA 510(k)SESE 510(k) Substantially Equivalent · Traditional	NumberK152781	Date12 Feb 2016Cleared	StatusActive

Official records

EUDAMED public site Basic UDI-DI B-06942674655879 — open Devices and search for it
FDA 510(k) database 510(k) number K152781

Across registries

2 registries list this device

EUDAMED Basic UDI-DI B-06942674655879 registered 24 Jun 2022 Active
FDA 510(k) K152781 decided 12 Feb 2016 Active

Timeline

2 dated events

12 Feb 2016 Cleared FDA 510(k) K152781
24 Jun 2022 Registered EUDAMED B-06942674655879

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

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

Specification

EUDAMED · 510(k)

Device name: Polyaxial Screw
Model / reference: Ⅳ(RF-1), 61112750

Primary DI / UDI-DI: 06942674655879
Basic UDI-DI: B-06942674655879
510(k) Number: K152781
FDA product code: NKB
EMDN code: P09070302 Thoracolumbosacral fixation systems

Device class: Class IIb EUDAMED
Class II 510(k)
Regulation: 21 CFR Part 888.3070
EU registration type: Legacy device (under a directive)
EU market of registration: Germany
Advisory committee: Orthopedic
FDA decision: SESE Substantially Equivalent

Truth per registry

2 sources · 1 field differs

Field	EUDAMED	510(k)
Device class	EUDAMED Class IIb	510(k) Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA 510(k)). EU and US classes are different schemes, so this is not a disagreement.

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.