K071420 is an FDA 510(k) clearance for the CHAMELEON FIXATION SYSTEM. This device is classified as a System, Facet Screw Spinal Device.
Submitted by Spinefrontier, Inc. (Beverly, US). The FDA issued a Cleared decision on January 16, 2008, 239 days after receiving the submission on May 22, 2007.
This device falls under the Orthopedic FDA review panel.
| 510(k) Number | K071420 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 22, 2007 |
| Decision Date | January 16, 2008 |
| Days to Decision | 239 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MRW - System, Facet Screw Spinal Device |
| Device Class | - |