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Piccolo Composite Plate System Drill Bit

by Carbofix Orthopedics Ltd 15 variants

Piccolo Composite Plate System Drill Bit (PL943125) is a Class II device made by Carbofix Orthopedics Ltd, cleared under FDA 510(k) K130061 on 27 Feb 2013 (1 earlier submission) and listed in FDA GUDID since 18 Sep 2016 (UDI-DI 07290109338668), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07290109338668 UDI-DI Date18 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK130061 Date27 Feb 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K130061 decided 27 Feb 2013 Active· +1 more in the status table
  • FDA GUDID UDI-DI 07290109338668 listed 18 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K102597
  2. Cleared FDA 510(k) K130061
  3. Listed FDA GUDID 07290109338668

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Piccolo Composite Plate System
Generic name
Fluted surgical drill bit, single-use
Model / Ref / Catalog
Drill Bit, PL943125
Primary DI / UDI-DI
07290109338668
510(k) Number
FDA product code
HWC, KTT, HRS
GMDN term
Fluted surgical drill bit, single-use
Device class
Class II
Regulation number
888.3040, 888.3030
GUDID distribution status
In Commercial Distribution
Size
Length — 125 Millimeter
Outer Diameter — 4.3 Millimeter

Related devices

Category: Fluted surgical drill bit, single-use

Cleared under the same submission (K102597)

and 8 more cleared under K102597

Cleared under the same submission (K130061)

and 8 more cleared under K130061

Similar devices in this category

Other devices filed under Fluted surgical drill bit, single-use.

Other devices from Carbofix Orthopedics Ltd

See all devices from Carbofix Orthopedics Ltd →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)