MODIFICATION TO STAXX FX SYSTEM
FDA 510(k) clearance K063606 · decided 2007-04-13
Clearance details
- K-number
- K063606
- Device name
- MODIFICATION TO STAXX FX SYSTEM
- Applicant
- Spine Wave, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-12-01
- Decision date
- 2007-04-13
- Days to decision
- 133 days
- Clearance type
- Traditional
- Product code
- OBL
- Device class
- 2
- Regulation number
- 888.3027
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Shelton, CT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.