Identity
- Trade Name
- Piccolo Composite Nailing System FDA UDI
- Generic Name
- Surgical drill guide, reusable FDA UDI
- Device Name
- Guide sleeve for use with the Piccolo Composite Proximal Femur Nailing System FDA UDI
- Model / Reference
- Soft Tissue Protector FDA UDI
- Description
- Guide sleeve for use with the Piccolo Composite Proximal Femur Nailing System FDA UDI
Identifiers
- Catalog Number
- PPF910210 FDA UDI
- Primary DI / UDI-DI
- 07290109337937 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Surgical drill guide, reusable 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
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 drill guide, reusable
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 Surgical drill guide, reusable.
- ORTHOFIX — Orthofix, Inc. · Class I
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- Truliant — Exactech, Inc. · Class II
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- Legion — Smith & Nephew, Inc. · Class II
- Hintermann Series — Dt Medtech, LLC · Class I
Cleared under the same submission
K151010 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
K153536 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
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 9ee7a79f-d983-42f6-b5b6-990b19b61155 36 fields · synced May 30, 2026