K-Wire Adapter 2120-00-030 212000030: CE/MDD Class IIa

Regulatory status

as of registry sync 7 Nov 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDD EUDAMED	NumberB-00887868446078 Basic UDI-DI 00887868446078UDI-DI	Date24 Oct 2026Registered	StatusActive
United States	GUDID listing GUDID	Number00887868446078 UDI-DI	Date17 Jul 2020Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK140622	Date13 May 2014Decided	StatusActive

Official records

EUDAMED public site Basic UDI-DI B-00887868446078 — open Devices and search for it
AccessGUDID record UDI-DI 00887868446078
FDA 510(k) database 510(k) number K140622

Across registries

3 registries list this device

EUDAMED Basic UDI-DI B-00887868446078 registered 24 Oct 2026 Active
FDA 510(k) K140622 decided 13 May 2014 Active
FDA GUDID UDI-DI 00887868446078 listed 17 Jul 2020 Listed

Recalls

1 recall · FDA

- Terminated Z-1082-2016 FDA Class II initiated 29 Jan 2016 on shared 510(k) K140622
Components of the DVR ePAKs can oxidize during shipment and storage prior to use. A delay in surgery, less than 30 minutes, may occur if the surgical staff proceeds to re-sterilize the product. If oxidative material would flake off a component contained within the ePAK and enter the surgical field/wound an inflammatory reaction may occur. The inflammatory reaction may result in a foreign body reaction and/or metal hypersensitivity. Oxidized components have failed cytotoxicity testing.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

4 dated events

13 May 2014 Cleared FDA 510(k) K140622
29 Jan 2016 Recall initiated FDA recalls Z-1082-2016
17 Jul 2020 Listed FDA GUDID 00887868446078
24 Oct 2026 Registered EUDAMED B-00887868446078

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Withdrawn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: K-Wire Adapter
Generic name: Surgical drill guide, single-use
Device name: DVR Crosslock KWire Adapter ST
Model / Ref / Catalog: 212000030, 2120-00-030

Primary DI / UDI-DI: 00887868446078
Basic UDI-DI: B-00887868446078
510(k) Number: K140622
FDA product code: HRS
EMDN code: P091399 Orthopaedic implant instruments, single-use - other
GMDN term: Surgical drill guide, single-use

Device class: Class IIa 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

Truth per registry

2 sources · 2 fields differ

Field	EUDAMED	GUDID
Model / reference	EUDAMED 212000030	GUDID 2120-00-030
Device class	EUDAMED Class IIa	GUDID Class II

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