Piccolo Composite Nailing System

FDA UDI

Class II (US FDA UDI)

by Carbofix Orthopedics Ltd

Identity

Trade Name: Piccolo Composite Nailing System FDA UDI
Generic Name: Cannulated surgical drill bit, single-use FDA UDI
Device Name: Drill Bit for use with the Piccolo Composite Proximal Femur Nailing System FDA UDI
Model / Reference: Lag Screw Step Drill Bit FDA UDI
Description: Drill Bit for use with the Piccolo Composite Proximal Femur Nailing System FDA UDI

Identifiers

Catalog Number: PPF910470 FDA UDI
Primary DI / UDI-DI: 07290109338064 FDA UDI
510(k) Number: K151010 FDA UDI
K153536 FDA UDI
FDA Product Code: HSB FDA UDI
GMDN Term: Cannulated surgical drill bit, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3020 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Lumen/Inner Diameter — 3.3 Millimeter FDA UDI
Length — 490 Millimeter FDA UDI

Category: Cannulated surgical drill bit, single-use

Piccolo Composite Nailing System by Carbofix Orthopedics Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cannulated surgical drill bit, single-use.

MEDLINE — MEDLINE INDUSTRIES, INC. · Class I
Sierra™ — SeaSpine Orthopedics Corporation · Class II
VersiTomic Low Profile Ø11.0 mm — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION · Class I
FOREFOOT SOLUTIONS™ — Newdeal Sas · Class I
APEX 3D S Total Ankle Replacement System — Paragon 28 · Class I
Arthrex® — Arthrex, Inc. · Class I
Arthrex® — Arthrex, Inc. · Class I
MEDLINE — MEDLINE INDUSTRIES, INC. · Class I

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Carbofix Orthopedics Ltd

Sources (1)

FDA UDI f9eb595b-cc92-4cd7-9757-9f8f87602d61 37 fields · synced May 30, 2026