MSB/None 8435545
by Medtronic Sofamor Danek, Inc.
MSB/None 8435545 is a Class II device made by Medtronic Sofamor Danek, Inc., cleared under FDA 510(k) K001532 on 16 Jun 2000 and listed in FDA GUDID since 19 Aug 2015 (UDI-DI 00673978950303), 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 | Number00673978950303 | Date19 Aug 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK001532 | Date16 Jun 2000 | StatusActive |
Official records
- AccessGUDID record 00673978950303
- FDA 510(k) database K001532
Across registries
- FDA 510(k) K001532 decided 16 Jun 2000 Active
- FDA GUDID UDI-DI 00673978950303 listed 19 Aug 2015 Listed
Timeline
- Cleared FDA 510(k) K001532
- Listed FDA GUDID 00673978950303
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- MSB/None
- Generic name
- Spinal bone screw, non-bioabsorbable
- Model / reference
- 8435545
- Primary DI / UDI-DI
- 00673978950303
- 510(k) Number
- FDA product code
- MNI, KWQ, KWP, MNH
- GMDN term
- Spinal bone screw, non-bioabsorbable
- Device class
- Class II
- Regulation number
- 888.3070, 888.3060, 888.3050
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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