Piccolo Composite Plate System

FDA UDI

Class II (US FDA UDI)

by Carbofix Orthopedics Ltd

Identity

Trade Name: Piccolo Composite Plate System FDA UDI
Generic Name: Periosteal elevator, reusable FDA UDI
Device Name: Periosteal Elevator for use with the Piccolo Composite Distal Radius Plate Systems FDA UDI
Model / Reference: Periosteal Elevator FDA UDI
Description: Periosteal Elevator for use with the Piccolo Composite Distal Radius Plate Systems FDA UDI

Identifiers

Catalog Number: PL921800 FDA UDI
Primary DI / UDI-DI: 07290110200749 FDA UDI
510(k) Number: K102597 FDA UDI
K160002 FDA UDI
FDA Product Code: HRS FDA UDI
KTT FDA UDI
GMDN Term: Periosteal elevator, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3030 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Periosteal elevator, reusable

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

Similar devices

Also classified as Periosteal elevator, reusable.

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MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
SCANLAN® Instrumentation — SCANLAN INTERNATIONAL INC · Class I
BARRIER PLACEMENT INSTRUMENT — W.H. Holden, Inc. · Class I
ELEVATOR — KLS-Martin L.P. · Class I
HELMUT ZEPF — Helmut Zepf Medizintechnik GmbH · Class I
Ambler Surgical — Ambler Surgical, LLC · 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

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Manufacturer

Manufacturer: Carbofix Orthopedics Ltd

Sources (1)

FDA UDI 6ec7b047-9d0d-48b8-9e2b-776da44f9667 36 fields · synced May 31, 2026