INTREPID SPINAL SYSTEM
FDA 510(k) clearance K080083 · decided 2008-04-10
Clearance details
- K-number
- K080083
- Device name
- INTREPID SPINAL SYSTEM
- Applicant
- Medtronic Sofamor Danek
- Decision
- Substantially Equivalent
- Date received
- 2008-01-11
- Decision date
- 2008-04-10
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- MAX
- Device class
- 2
- Regulation number
- 888.3080
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Memphis, TN, US
- Third-party review
- No
- Expedited review
- No
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