Dyna-Lok Classic Spinal System
by Medtronic Sofamor Danek, Inc. 2 variants
510(k) K001532
Dyna-Lok Classic Spinal System is a Class II device made by Medtronic Sofamor Danek, Inc., cleared under FDA 510(k) K001532 on 16 Jun 2000, 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 | FDA 510(k)SESE | NumberK001532 | Date16 Jun 2000 | StatusActive |
Official records
- FDA 510(k) database K001532
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KWP
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3050
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K001532
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| MSB/None 8435005 | 8435005 | 00673978950259 | — | On the market |
| MSB/None 8435540 | 8435540 | 00673978950297 | — | On the market |
| MSB/None 8435545 | 8435545 | 00673978950303 | — | On the market |
| MSB/None 8436535 | 8436535 | 00673978950341 | — | On the market |
| MSB/None 8436540 | 8436540 | 00673978950358 | — | On the market |
| MSB/None 8436545 | 8436545 | 00673978950365 | — | On the market |
| MSB/None 8436550 | 8436550 | 00673978950372 | — | No longer on the market |
| MSB/None 8437035 | 8437035 | 00673978950396 | — | On the market |
| MSB/None 8437040 | 8437040 | 00673978950402 | — | On the market |
| MSB/None 8437045 | 8437045 | 00673978950419 | — | On the market |
| MSB/None 8437050 | 8437050 | 00673978950426 | — | On the market |
| MSB/None 8437540 | 8437540 | 00673978950501 | — | On the market |
| MSB/None 8437545 | 8437545 | 00673978950518 | — | On the market |
| MSB/None 8437550 | 8437550 | 00673978950525 | — | On the market |
Similar devices
Other devices filed under FDA product code KWP (Appliance, Fixation, Spinal Interlaminal).
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