510(k) K071420
K071420 is an FDA 510(k) premarket notification submitted by Spinefrontier, Inc. for the device "CHAMELEON FIXATION SYSTEM". The FDA issued a decision of Substantially Equivalent on Jan 16, 2008. The device falls under product code MRW (System, Facet Screw Spinal Device), a Class U device. Spinefrontier, Inc. has 23 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 16, 2008
- Date Received
- May 22, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- System, Facet Screw Spinal Device
- Device Class
- Class U
- Review Panel
- OR
- Submission Type
- 510(k)