Colorado 2 Spinal System
by Medtronic Sofamor Danek, Inc.
510(k) K020247
Colorado 2 Spinal System is a Class II device made by Medtronic Sofamor Danek, Inc., cleared under FDA 510(k) K020247 on 22 Jul 2002, 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 | NumberK020247 | Date22 Jul 2002 | StatusActive |
Official records
- FDA 510(k) database K020247
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MNH
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3070
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K020247
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 84505LH | 84505LH | 00673978057460 | — | On the market |
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