MALIBU SPINAL SYSTEM
FDA 510(k) clearance K051942 · decided 2005-07-27
Clearance details
- K-number
- K051942
- Device name
- MALIBU SPINAL SYSTEM
- Applicant
- Seaspine, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-07-15
- Decision date
- 2005-07-27
- Days to decision
- 12 days
- Clearance type
- Traditional
- Product code
- KWP
- Device class
- 2
- Regulation number
- 888.3050
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Vista, CA, US
- Third-party review
- No
- Expedited review
- No
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