Set Screw 101-10001
by OsteoCentric Technologies, Inc
Set Screw 101-10001 is a Class II device made by OsteoCentric Technologies, Inc, cleared under FDA 510(k) K221332 on 28 Jul 2022 and listed in FDA GUDID since 13 Apr 2023 (UDI-DI 00810097802483), active as of 22 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 | Number00810097802483 | Date13 Apr 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK221332 | Date28 Jul 2022 | StatusActive |
Official records
- AccessGUDID record 00810097802483
- FDA 510(k) database K221332
Across registries
- FDA 510(k) K221332 decided 28 Jul 2022 Active
- FDA GUDID UDI-DI 00810097802483 listed 13 Apr 2023 Listed
Timeline
- Cleared FDA 510(k) K221332
- Listed FDA GUDID 00810097802483
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Set Screw
- Generic name
- Spinal bone set screw
- Model / Ref / Catalog
- 101-10001
- Primary DI / UDI-DI
- 00810097802483
- 510(k) Number
- FDA product code
- NKB
- GMDN term
- Spinal bone set screw
- Device class
- Class II
- Regulation number
- 888.3070
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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