Identity
- Trade Name
- Piccolo Composite Systems FDA UDI
- Generic Name
- Surgical instrument handle, non-torque-limiting FDA UDI
- Device Name
- Handle for use with the Piccolo Composite Distal Femur Plate System and Ankle Arthrodesis Nailing System FDA UDI
- Model / Reference
- Opening Pin FDA UDI
- Description
- Handle for use with the Piccolo Composite Distal Femur Plate System and Ankle Arthrodesis Nailing System FDA UDI
Identifiers
- Catalog Number
- PFT912220 FDA UDI
- Primary DI / UDI-DI
- 07290110200954 FDA UDI
- FDA Product Code
- KTT FDA UDIHRS FDA UDIHSB FDA UDI
- GMDN Term
- Surgical instrument handle, non-torque-limiting FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI888.3020 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical instrument handle, non-torque-limiting
Piccolo Composite Systems by Carbofix Orthopedics Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Surgical instrument handle, non-torque-limiting.
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Cleared under the same submission
K123810 also covers:
- Piccolo Composite Nailing System — CARBOFIX ORTHOPEDICS LTD
- Piccolo Composite Nailing System — CARBOFIX ORTHOPEDICS LTD
- Piccolo Composite Nailing System — CARBOFIX ORTHOPEDICS LTD
- Piccolo Composite Nailing System — CARBOFIX ORTHOPEDICS LTD
- Piccolo Composite Nailing System — CARBOFIX ORTHOPEDICS LTD
- Piccolo Composite Nailing System — CARBOFIX ORTHOPEDICS LTD
- Piccolo Composite Nailing System — CARBOFIX ORTHOPEDICS LTD
- Piccolo Composite Nailing System — CARBOFIX ORTHOPEDICS LTD
- Piccolo Composite Nailing System — CARBOFIX ORTHOPEDICS LTD
- Piccolo Composite Nailing System — CARBOFIX ORTHOPEDICS LTD
- Piccolo Composite Nailing System — CARBOFIX ORTHOPEDICS LTD
- Piccolo Composite Nailing System — CARBOFIX ORTHOPEDICS LTD
K143496 also covers:
- Piccolo Composite Plate System — CARBOFIX ORTHOPEDICS LTD
- Piccolo Composite Plate System — CARBOFIX ORTHOPEDICS LTD
- Piccolo Composite Plate System — CARBOFIX ORTHOPEDICS LTD
- Piccolo Composite Plate System — CARBOFIX ORTHOPEDICS LTD
- Piccolo Composite Plate System — CARBOFIX ORTHOPEDICS LTD
- Piccolo Composite Plate System — CARBOFIX ORTHOPEDICS LTD
- Piccolo Composite Plate System — CARBOFIX ORTHOPEDICS LTD
- Piccolo Composite Plate System — CARBOFIX ORTHOPEDICS LTD
- Piccolo Composite Plate System — CARBOFIX ORTHOPEDICS LTD
- Piccolo Composite Plate System — CARBOFIX ORTHOPEDICS LTD
- Piccolo Composite Plate System — CARBOFIX ORTHOPEDICS LTD
- Piccolo Composite Plate System — CARBOFIX ORTHOPEDICS LTD
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 42dc0c53-4c4f-496d-b405-cf4d7f3d503b 36 fields · synced Jun 6, 2026