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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
Bone nail end-cap FDA UDI
Device Name
Nail cap for tibial, femoral, ankle arthrodesis nails FDA UDI
Model / Reference
Nail Cap FDA UDI
Description
Nail cap for tibial, femoral, ankle arthrodesis nails FDA UDI

Identifiers

Catalog Number
PTNC9000 FDA UDI
Primary DI / UDI-DI
07290109332758 FDA UDI
510(k) Number
K102369 FDA UDI
K111056 FDA UDI
K123810 FDA UDI
K132774 FDA UDI
FDA Product Code
HSB FDA UDI
GMDN Term
Bone nail end-cap 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

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Dimensions & Sizes

Size
Length — 4 Millimeter FDA UDI

Category: Bone nail end-cap

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 Bone nail end-cap.

Cleared under the same submission

K102369 also covers:

K111056 also covers:

K123810 also covers:

K132774 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Carbofix Orthopedics Ltd

Sources (1)

  • FDA UDI c977d5b3-57a6-4339-8e88-40601a549f5d 36 fields · synced Jun 8, 2026