Identity
- Trade Name
- Piccolo Composite Plate System FDA UDI
- Generic Name
- Fluted surgical drill bit, single-use FDA UDI
- Device Name
- Drill Bit for use with the Piccolo Composite Distal Fibula and One Third Tubular Plate Systems FDA UDI
- Model / Reference
- Drill Bit FDA UDI
- Description
- Drill Bit for use with the Piccolo Composite Distal Fibula and One Third Tubular Plate Systems FDA UDI
Identifiers
- Catalog Number
- PL935115 FDA UDI
- Primary DI / UDI-DI
- 07290109338651 FDA UDI
- 510(k) Number
- K120409 FDA UDI
- FDA Product Code
- KTT FDA UDIHRS FDA UDI
- GMDN Term
- Fluted surgical drill bit, single-use 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
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 115 Millimeter FDA UDIOuter Diameter — 3.5 Millimeter FDA UDI
Category: Fluted surgical drill bit, single-use
Piccolo Composite Plate System by Carbofix Orthopedics Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K120409 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 |
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Manufacturer
- Manufacturer
- Carbofix Orthopedics Ltd
Sources (1)
- FDA UDI d127b611-58a7-4917-b71f-9e1ddac9e0b2 37 fields · synced May 30, 2026