Identity
- Trade Name
- Piccolo Composite Plate System FDA UDI
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
- Device Name
- Tibial Medial plate intended to buttress metaphyseal fractures of the medial tibia plateau, split-type fractures of the medial tibia plateau, medial split fractures with associated depressions and split or depression fractures of the medial tibia plateau. The plates may also be used for fixation of the proximal quarter (lateral and medial) of the tibia as well as segmental fractures of the proximal tibia. FDA UDI
- Model / Reference
- Tibial Medial Plate, 6 holes, Left FDA UDI
- Description
- Tibial Medial plate intended to buttress metaphyseal fractures of the medial tibia plateau, split-type fractures of the medial tibia plateau, medial split fractures with associated depressions and split or depression fractures of the medial tibia plateau. The plates may also be used for fixation of the proximal quarter (lateral and medial) of the tibia as well as segmental fractures of the proximal tibia. FDA UDI
Identifiers
- Catalog Number
- PTML0006 FDA UDI
- Primary DI / UDI-DI
- 07290110207779 FDA UDI
- 510(k) Number
- K201917 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Orthopaedic fixation plate, non-bioabsorbable 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
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
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Length — 112 Millimeter FDA UDI
Category: Orthopaedic fixation plate, non-bioabsorbable
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
K201917 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 7ac35c91-26f5-4bf9-b522-1f498b195545 37 fields · synced May 31, 2026