Skip to content

Piccolo Composite Proximal Tibia Plate System

by Carbofix Orthopedics Ltd

510(k) K201917Ref PTLR0010

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

CE MDR 510(k)

Valid until

Not listed

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

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K201917↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number729011020CARBOFIX065V7 Basic UDI-DI 07290110207748UDI-DIDate29 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07290110207748 UDI-DI Date14 Feb 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK201917 Date8 Oct 2020ClearedStatusActive

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 22 Oct 2026.

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  • Withdrawn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 · 510(k) · 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
PTLR0010, Tibial Lateral Plate, 10 holes, Right
FDA applicant
CarboFix Orthopedics , Ltd.
Primary DI / UDI-DI
07290110207748
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 510(k)GUDID
Regulation
21 CFR Part 888.3030
Market of Registration
Italy
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional
Size
Length — 177 Millimeter

Truth per registry

3 sources · 2 fields differ

FieldEUDAMED510(k)GUDID
Model / ReferenceEUDAMED
PTLR0010
510(k)
—
GUDID
Tibial Lateral Plate, 10 holes, Right
Device ClassEUDAMED
Class IIb
510(k)
Class II
GUDID
Class II

Other devices from Carbofix Orthopedics Ltd

See all devices from Carbofix Orthopedics Ltd →

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