Aptus A-4856.13
Aptus A-4856.13 is a Class II device made by Medartis Inc., cleared under FDA 510(k) K103332 on 24 Jan 2011 and listed in FDA GUDID since 24 Oct 2015 (UDI-DI 07630008459857), 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 | Number07630008459857 | Date24 Oct 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK103332 | Date24 Jan 2011 | StatusActive |
Official records
- AccessGUDID record 07630008459857
- FDA 510(k) database K103332
Across registries
- FDA 510(k) K103332 decided 24 Jan 2011 Active
- FDA GUDID UDI-DI 07630008459857 listed 24 Oct 2015 Listed
Timeline
- Cleared FDA 510(k) K103332
- Listed FDA GUDID 07630008459857
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Aptus
- Generic name
- Orthopaedic fixation plate, non-bioabsorbable, non-sterile
- Model / Ref / Catalog
- A-4856.13
- Primary DI / UDI-DI
- 07630008459857
- 510(k) Number
- FDA product code
- HRS
- GMDN term
- Orthopaedic fixation plate, non-bioabsorbable, non-sterile
- Device class
- Class II
- Regulation number
- 888.3030
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization