Glaxy 3.2 Spinal System
by Medtronic Sofamor Danek, Inc.
510(k) K043020
Glaxy 3.2 Spinal System is a Class II device made by Medtronic Sofamor Danek, Inc., cleared under FDA 510(k) K043020 on 7 Jan 2005, 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 | NumberK043020 | Date7 Jan 2005 | StatusActive |
Official records
- FDA 510(k) database K043020
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KWP
- FDA applicant
- Medtronic Sofamor Danek
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3050
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K043020
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 | |||
|---|---|---|---|---|
| VERTEX® Reconstruction System X2390160 | X2390160 | 00885074531519 | — | On the market |
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