Modification to: Vertex Reconstruction System
by Medtronic Sofamor Danek, Inc. 2 variants
510(k) K052376
Modification to: Vertex Reconstruction System is a Class II device made by Medtronic Sofamor Danek, Inc., cleared under FDA 510(k) K052376 on 23 Sep 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 | NumberK052376 | Date23 Sep 2005 | StatusActive |
Official records
- FDA 510(k) database K052376
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- Withdrawn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 K052376
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 X09804132 | X09804132 | 00721902794247 | — | No longer on the market |
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