Identity
- Trade Name
- Piccolo Composite Plate System FDA UDI
- Generic Name
- Orthopaedic bone screw (non-sliding) FDA UDI
- Device Name
- Locking screw for use with proximal humerus plate FDA UDI
- Model / Reference
- Locking Screw FDA UDI
- Description
- Locking screw for use with proximal humerus plate FDA UDI
Identifiers
- Catalog Number
- PHTST35450 FDA UDI
- Primary DI / UDI-DI
- 07290109333700 FDA UDI
- 510(k) Number
- K102597 FDA UDI
- FDA Product Code
- KTT FDA UDIHRS FDA UDI
- GMDN Term
- Orthopaedic bone screw (non-sliding) 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
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Length — 45 Millimeter FDA UDIOuter Diameter — 3.5 Millimeter FDA UDI
Category: Orthopaedic bone screw (non-sliding)
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 Orthopaedic bone screw (non-sliding).
- EVOS — Smith & Nephew, Inc. · Class II
- TriLeap Lower Extremity Anatomic Plating System — CROSSROADS EXTREMITY SYSTEMS LLC · Class II
- Arthrex® — Arthrex, Inc. · Class II
- Zavation — ZAVATION · Class II
- STARDRIVE — Synthes GmbH · Class IIb
- Arthrex® — Arthrex, Inc. · Class II
- Cancellous Screw, Locking — I.T.S. GmbH · Class II
- PANGEA — Stryker Corp. · Class II
Cleared under the same submission
K102597 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 6a9b4c1b-f2b2-4666-82fe-fd11e30d30f3 36 fields · synced May 30, 2026