Basis Spinal System
by Medtronic Sofamor Danek, Inc. 2 variants
510(k) K060081
Basis Spinal System is a Class II device made by Medtronic Sofamor Danek, Inc., cleared under FDA 510(k) K060081 on 13 Feb 2006, 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 | NumberK060081 | Date13 Feb 2006 | StatusActive |
Official records
- FDA 510(k) database K060081
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- Withdrawn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
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