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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
Femoral neck fixation sliding bone screw FDA UDI
Device Name
Lag screw for use with proximal femur nails. FDA UDI
Model / Reference
Lag Screw FDA UDI
Description
Lag screw for use with proximal femur nails. FDA UDI

Identifiers

Catalog Number
PPFLS10085 FDA UDI
Primary DI / UDI-DI
07290109337845 FDA UDI
510(k) Number
K151010 FDA UDI
K153536 FDA UDI
FDA Product Code
HSB FDA UDI
GMDN Term
Femoral neck fixation sliding bone screw 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

Dimensions & Sizes

Size
Outer Diameter — 10.4 Millimeter FDA UDI
Length — 85 Millimeter FDA UDI

Category: Femoral neck fixation sliding bone screw

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 Femoral neck fixation sliding bone screw.

Cleared under the same submission

K151010 also covers:

K153536 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 86dcd90f-b38c-4956-a946-7ae104763611 37 fields · synced May 31, 2026