Piccolo Composite Plate System
by Carbofix Orthopedics Ltd 2 variants
510(k) K182015
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK182015 | Date11 Oct 2018 | StatusActive |
Official records
- FDA 510(k) database K182015
- FDA 510(k) database K170401
Timeline
- Cleared FDA 510(k) K170401
- Cleared FDA 510(k) K182015
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- HRS
- FDA applicant
- CarboFix Orthopedics , Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3030
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Piccolo Composite Plate System is a composite orthopedic fixation device designed for internal fixation of long bone fractures. It combines a titanium alloy plate with a composite material to provide enhanced stability and load distribution during bone healing, as classified under orthopedic fixation systems.
This system is supplied as a sterile, single-use device intended for use in operating room settings. It is available in various sizes and configurations to accommodate different anatomical requirements, with regulatory clearance under the FDA’s 510(k) pathway as substantially equivalent to predicate devices. Storage and handling must adhere to manufacturer guidelines to maintain sterility and performance integrity.