K163366 is an FDA 510(k) clearance for the Shanghai Sanyou CARMEN Cervical Fusion System. This device is classified as a Appliance, Fixation, Spinal Intervertebral Body (Class II - Special Controls, product code KWQ).
Submitted by Shanghai Sanyou Medical Co, Ltd. (Jiading District, CN). The FDA issued a Cleared decision on October 5, 2017, 309 days after receiving the submission on November 30, 2016.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3060.
| 510(k) Number | K163366 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 30, 2016 |
| Decision Date | October 05, 2017 |
| Days to Decision | 309 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KWQ - Appliance, Fixation, Spinal Intervertebral Body |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3060 |