SAVANNAH LUMBAR PERCUTANEOUS STABILIZATION SYSTEM
FDA 510(k) clearance K072116 · decided 2008-03-20
Clearance details
- K-number
- K072116
- Device name
- SAVANNAH LUMBAR PERCUTANEOUS STABILIZATION SYSTEM
- Applicant
- Neurospine Innovations and Solutions
- Decision
- Substantially Equivalent
- Date received
- 2007-08-01
- Decision date
- 2008-03-20
- Days to decision
- 232 days
- Clearance type
- Traditional
- Product code
- NKB
- Device class
- 2
- Regulation number
- 888.3070
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Apple Valley, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.