K063181 is an FDA 510(k) clearance for the SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM. This device is classified as a Prosthesis, Condyle, Mandibular, Temporary (Class II - Special Controls, product code NEI).
Submitted by Synthes (Usa) (West Chester, US). The FDA issued a Cleared decision on January 5, 2007, 78 days after receiving the submission on October 19, 2006.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4770.
| 510(k) Number | K063181 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 19, 2006 |
| Decision Date | January 05, 2007 |
| Days to Decision | 78 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | NEI — Prosthesis, Condyle, Mandibular, Temporary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.4770 |