SPINAL CONCEPTS INC. PATHFINDER
FDA 510(k) clearance K030625 · decided 2003-03-28
Clearance details
- K-number
- K030625
- Device name
- SPINAL CONCEPTS INC. PATHFINDER
- Applicant
- Spinal Concepts, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-02-27
- Decision date
- 2003-03-28
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- NKB
- Device class
- 2
- Regulation number
- 888.3070
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
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