MSB/None 8437545
by Medtronic Sofamor Danek, Inc.
MSB/None 8437545 is a spinal bone screw (FDA Class II) 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 00673978950518), 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 | Number00673978950518 | Date19 Aug 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK001532 | Date16 Jun 2000 | StatusActive |
Official records
- AccessGUDID record 00673978950518
- FDA 510(k) database K001532
Across registries
- FDA 510(k) K001532 decided 16 Jun 2000 Active
- FDA GUDID UDI-DI 00673978950518 listed 19 Aug 2015 Listed
Timeline
- Cleared FDA 510(k) K001532
- Listed FDA GUDID 00673978950518
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- Withdrawn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
- 8437545
- Primary DI / UDI-DI
- 00673978950518
- 510(k) Number
- FDA product code
- KWP, MNI, MNH, KWQ
- GMDN term
- Spinal bone screw, non-bioabsorbable
- Device class
- Class II
- Regulation number
- 888.3050, 888.3070, 888.3060
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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