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Percutaneous Compression Plate (Pc.c.p) 1

by Orthofix, Inc. 7 variants

Ref 192000Model VARIOUS ORTHOPEDIC AND TRAUMATOLOGY INSTRUMENTS - OTHERS Instrumentation for insertion and extraction of implantable plates

Percutaneous Compression Plate (Pc.c.p) 1 (192000) is a device classified as Class IIa in the EU and Class II in the US made by Orthofix, Inc., registered in EUDAMED on 22 Oct 2026 (Basic UDI-DI 805050436NStInsPla2a258E), cleared under FDA 510(k) K983814 on 14 Jan 1999 and listed in FDA GUDID since 18 Apr 2018 (UDI-DI 18032568865837), active as of 7 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K983814

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number805050436NStInsPla2a258E Basic UDI-DI 18032568865837UDI-DIDate22 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number18032568865837 UDI-DI Date18 Apr 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK983814 Date14 Jan 1999DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 805050436NStInsPla2a258E registered 22 Oct 2026 Active
  • FDA 510(k) K983814 decided 14 Jan 1999 Active
  • FDA GUDID UDI-DI 18032568865837 listed 18 Apr 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K983814
  2. Listed FDA GUDID 18032568865837
  3. Registered EUDAMED 805050436NStInsPla2a258E

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Orthofix Surgical Instruments EUDAMED
Percutaneous Compression Plate (Pc.c.p) GUDID
Generic name
General internal orthopaedic fixation system implantation kit
Model / Ref / Catalog
VARIOUS ORTHOPEDIC AND TRAUMATOLOGY INSTRUMENTS - OTHERS Instrumentation for insertion and extraction of implantable plates, 192000, 1
Primary DI / UDI-DI
18032568865837
Basic UDI-DI
805050436NStInsPla2a258E
510(k) Number
FDA product code
JDO
EMDN code
Z12139099 Various orthopaedic and traumatology instruments - other
GMDN term
General internal orthopaedic fixation system implantation kit
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
888.3030
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
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.

Related devices

Category: General internal orthopaedic fixation system implantation kit

Cleared under the same submission (K983814)

and 8 more cleared under K983814

Similar devices in this category

Other devices filed under VARIOUS ORTHOPAEDIC AND TRAUMATOLOGY INSTRUMENTS.

Other devices from Orthofix, Inc.

See all devices from Orthofix, Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)