K133906 is an FDA 510(k) clearance for the C-JAWS CERVICAL COMPRESSIVE STAPLE. This device is classified as a Anterior Staple As Supplemental Fixation For Fusion (Class II - Special Controls, product code PHQ).
Submitted by Medicrea International (Washington, US). The FDA issued a Cleared decision on July 24, 2014, 213 days after receiving the submission on December 23, 2013.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3060. Anterior Cervical Device For Supplemental Fixation To Support A Fusion..
| 510(k) Number | K133906 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 2013 |
| Decision Date | July 24, 2014 |
| Days to Decision | 213 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | PHQ - Anterior Staple As Supplemental Fixation For Fusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3060 |
| Definition | Anterior Cervical Device For Supplemental Fixation To Support A Fusion. |