Sochi A16-10-3520
by Altus Spine
Sochi A16-10-3520 is a Class II device made by Altus Spine, cleared under FDA 510(k) K210887 on 20 Aug 2021 and listed in FDA GUDID since 28 Dec 2023 (UDI-DI 00843210166261), 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 | Number00843210166261 | Date28 Dec 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK210887 | Date20 Aug 2021 | StatusActive |
Official records
- AccessGUDID record 00843210166261
- FDA 510(k) database K210887
Across registries
- FDA 510(k) K210887 decided 20 Aug 2021 Active
- FDA GUDID UDI-DI 00843210166261 listed 28 Dec 2023 Listed
Timeline
- Cleared FDA 510(k) K210887
- Listed FDA GUDID 00843210166261
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Sochi
- Generic name
- Spinal bone screw, non-bioabsorbable
- Model / reference
- A16-10-3520
- Primary DI / UDI-DI
- 00843210166261
- 510(k) Number
- FDA product code
- KWP, NKG
- GMDN term
- Spinal bone screw, non-bioabsorbable
- Device class
- Class II
- Regulation number
- 888.3050, 888.3075
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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