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Percutaneous Compression Plate (Pc.c.p) 1

by Orthofix, Inc. 7 variants

Ref 200000

Percutaneous Compression Plate (Pc.c.p) 1 (200000) is a device classified as Class I in the EU and Class II in the US made by Orthofix, Inc., registered in EUDAMED on 6 Oct 2026 (Basic UDI-DI B-18032568865912), cleared under FDA 510(k) K983814 on 14 Jan 1999 and listed in FDA GUDID since 19 Apr 2018 (UDI-DI 18032568865912), active as of 24 Oct 2026.

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

CE MDD 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K983814

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-18032568865912 Basic UDI-DI 18032568865912UDI-DIDate6 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number18032568865912 UDI-DI Date19 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 B-18032568865912 registered 6 Oct 2026 Active
  • FDA 510(k) K983814 decided 14 Jan 1999 Active
  • FDA GUDID UDI-DI 18032568865912 listed 19 Apr 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K983814
  2. Listed FDA GUDID 18032568865912
  3. Registered EUDAMED B-18032568865912

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Percutanoeus Compression Plate (PC.C.P) EUDAMED
Percutaneous Compression Plate (Pc.c.p) GUDID
Generic name
General internal orthopaedic fixation system implantation kit
Model / Ref / Catalog
200000, 1
Primary DI / UDI-DI
18032568865912
Basic UDI-DI
B-18032568865912
510(k) Number
FDA product code
JDO
EMDN code
P091280 Osteosynthesis devices, devices for tendon and ligament synthesis - accessories
GMDN term
General internal orthopaedic fixation system implantation kit
Device class
Class I EUDAMED
Class II GUDID
Regulation number
888.3030
System or procedure pack
System which is a device in itself
EU registration type
Legacy device (under a directive)
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
200000
GUDID
1
Device classEUDAMED
Class I
GUDID
Class II
Sterilise before useEUDAMED
No
GUDID
Yes

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 18032568865912: EUDAMED states No, FDA GUDID states Yes.

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.

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 OSTEOSYNTHESIS DEVICES, DEVICES FOR TENDON AND LIGAMENT SYNTHESIS - ACCESSORIES.

Other devices from Orthofix, Inc.

See all devices from Orthofix, Inc. →

Properties

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