Piccolo Composite Plate System… PLCNN4509: CE/MDR Class IIb

Regulatory status

as of registry sync 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR EUDAMED	Number729011020CARBOFIX007UR Basic UDI-DI 07290109334813UDI-DI	Date28 Sep 2026Registered	StatusActive
United States	GUDID listing GUDID	Number07290109334813 UDI-DI	Date18 Oct 2015Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special	NumberK130061	Date27 Feb 2013Decided	StatusActive
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK102597	Date24 Feb 2011Decided	StatusActive

Official records

EUDAMED public site Basic UDI-DI 729011020CARBOFIX007UR — open Devices and search for it
AccessGUDID record UDI-DI 07290109334813
FDA 510(k) database 510(k) number K130061
FDA 510(k) database 510(k) number K102597

Across registries

3 registries list this device

EUDAMED Basic UDI-DI 729011020CARBOFIX007UR registered 28 Sep 2026 Active
FDA 510(k) K130061 decided 27 Feb 2013 Active· +1 more in the status table
FDA GUDID UDI-DI 07290109334813 listed 18 Oct 2015 Listed

Timeline

4 dated events

24 Feb 2011 Cleared FDA 510(k) K102597
27 Feb 2013 Cleared FDA 510(k) K130061
18 Oct 2015 Listed FDA GUDID 07290109334813
28 Sep 2026 Registered EUDAMED 729011020CARBOFIX007UR

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

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

Specification

EUDAMED · GUDID

Trade name: Piccolo Composite ® Diaphyseal Plate EUDAMED
Piccolo Composite Plate System GUDID
Generic name: Orthopaedic fixation plate, non-bioabsorbable
Device name: Diaphyseal Plates
Model / Ref / Catalog: PLCNN4509, Diaphyseal Plate - Narrow

Primary DI / UDI-DI: 07290109334813
Basic UDI-DI: 729011020CARBOFIX007UR
510(k) Number: K102597
K130061
FDA product code: HWC, HRS, KTT
EMDN code: P09120599 Bone fixation plates - other
GMDN term: Orthopaedic fixation plate, non-bioabsorbable

Device class: Class IIb EUDAMED
Class II GUDID
Regulation number: 888.3040, 888.3030
EU registration type: Standard device
EU market of registration: Italy
GUDID distribution status: In Commercial Distribution

Size: Length — 190 Millimeter

Truth per registry

2 sources · 2 fields differ

Field	EUDAMED	GUDID
Model / reference	EUDAMED PLCNN4509	GUDID Diaphyseal Plate - Narrow
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.