Vertex Rcconstruction System
by Medtronic Sofamor Danek, Inc.
510(k) K121191
Vertex Rcconstruction System is a Class II device made by Medtronic Sofamor Danek, Inc., cleared under FDA 510(k) K121191 on 29 Jun 2012, 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 | NumberK121191 | Date29 Jun 2012 | StatusActive |
Official records
- FDA 510(k) database K121191
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- Withdrawn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 K121191
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 | |||
|---|---|---|---|---|
| CD HORIZON® Spinal System X0508080 | X0508080 | 00613994531803 | Length 40.0 mm | On the market |
| VERTEX® Reconstruction System X0508075 | X0508075 | 00613994531759 | Length 30.0 mm | On the market |
| VERTEX® Reconstruction System X0508076 | X0508076 | 00613994531766 | Length 32.0 mm | On the market |
| VERTEX® Reconstruction System X0508077 | X0508077 | 00613994531773 | Length 34.0 mm | On the market |
| VERTEX® Reconstruction System X0508078 | X0508078 | 00613994531780 | Length 36.0 mm | On the market |
| VERTEX® Reconstruction System X0508079 | X0508079 | 00613994531797 | Length 38.0 mm | On the market |
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