Percutaneous Compression Plate (Pc.c.p) 1
Percutaneous Compression Plate (Pc.c.p) 1 (184000) is a Class II device made by Orthofix, Inc., cleared under FDA 510(k) K983814 on 14 Jan 1999 and listed in FDA GUDID since 24 Apr 2018 (UDI-DI 18032568865752), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number18032568865752 | Date24 Apr 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK983814 | Date14 Jan 1999 | StatusActive |
Official records
- AccessGUDID record 18032568865752
- FDA 510(k) database K983814
Across registries
- FDA 510(k) K983814 decided 14 Jan 1999 Active
- FDA GUDID UDI-DI 18032568865752 listed 24 Apr 2018 Listed
Timeline
- Cleared FDA 510(k) K983814
- Listed FDA GUDID 18032568865752
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Percutaneous Compression Plate (Pc.c.p)
- Generic name
- General internal orthopaedic fixation system implantation kit
- Model / Ref / Catalog
- 1, 184000
- Primary DI / UDI-DI
- 18032568865752
- 510(k) Number
- FDA product code
- JDO
- GMDN term
- General internal orthopaedic fixation system implantation kit
- Device class
- Class II
- Regulation number
- 888.3030
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Similar devices in this category
Other devices filed under General internal orthopaedic fixation system implantation kit.