K142980 is an FDA 510(k) clearance for the Proficient (TM) Facet Screw Spine System. This device is classified as a System, Facet Screw Spinal Device.
Submitted by Spine Wave, Inc. (Shelton, US). The FDA issued a Cleared decision on January 16, 2015, 93 days after receiving the submission on October 15, 2014.
This device falls under the Orthopedic FDA review panel.
| 510(k) Number | K142980 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 15, 2014 |
| Decision Date | January 16, 2015 |
| Days to Decision | 93 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MRW — System, Facet Screw Spinal Device |
| Device Class | — |