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Piccolo Composite Plate System Tibial Medial Plate, 10 holes, Left

by Carbofix Orthopedics Ltd

Ref PTML0010

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number729011020CARBOFIX065V7 Basic UDI-DI 07290110207793UDI-DIDate29 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07290110207793 UDI-DI Date14 Feb 2021ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Piccolo Composite ® Proximal Tibia Plate EUDAMED
Piccolo Composite Plate System GUDID
Generic Name
Orthopaedic fixation plate, non-bioabsorbable
Device Name
Proximal Tibia Plates
Model / Ref / Catalog
PTML0010, Tibial Medial Plate, 10 holes, Left
Primary DI / UDI-DI
07290110207793
Basic UDI-DI
729011020CARBOFIX065V7
510(k) Number
FDA Product Code
HRS
EMDN Code
P09120599 Bone fixation plates - other
GMDN Term
Orthopaedic fixation plate, non-bioabsorbable
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
888.3030
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional
Size
Length — 166 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
PTML0010
GUDID
Tibial Medial Plate, 10 holes, Left
Device ClassEUDAMED
Class IIb
GUDID
Class II

Related devices

Category: Orthopaedic fixation plate, non-bioabsorbable

Cleared under the same submission (K201917)

Show all (12)

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Sutures
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (18)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No