Aptus A-4099.21
by Medartis AG
Aptus A-4099.21 is a Class II device made by Medartis AG, cleared under FDA 510(k) K193639 on 26 Mar 2020 and listed in FDA GUDID since 22 May 2020 (UDI-DI 07630037832881), active as of 12 Nov 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 | Number07630037832881 | Date22 May 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK193639 | Date26 Mar 2020 | StatusActive |
Official records
- AccessGUDID record 07630037832881
- FDA 510(k) database K193639
Across registries
- FDA 510(k) K193639 decided 26 Mar 2020 Active
- FDA GUDID UDI-DI 07630037832881 listed 22 May 2020 Listed
Timeline
- Cleared FDA 510(k) K193639
- Listed FDA GUDID 07630037832881
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- Withdrawn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-4099.21
- Primary DI / UDI-DI
- 07630037832881
- 510(k) Number
- FDA product code
- PLF
- 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
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