K120177 is an FDA 510(k) clearance for the SPINAL ELEMENTS CERCLAGE SYSTEM. This device is classified as a Cerclage, Fixation (Class II - Special Controls, product code JDQ).
Submitted by Spinal Elements, Inc. (Carlsbad, US). The FDA issued a Cleared decision on July 3, 2012, 165 days after receiving the submission on January 20, 2012.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3010.
| 510(k) Number | K120177 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 20, 2012 |
| Decision Date | July 03, 2012 |
| Days to Decision | 165 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | JDQ — Cerclage, Fixation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3010 |