K161548 is an FDA 510(k) clearance for the Osseointegrated Fixtures. This device is classified as a Prosthesis, Nose, Internal (Class II - Special Controls, product code FZE).
Submitted by Southern Implants (Pty), Ltd. (Irene, ZA). The FDA issued a Cleared decision on December 1, 2016, 181 days after receiving the submission on June 3, 2016.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3680.
| 510(k) Number | K161548 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 03, 2016 |
| Decision Date | December 01, 2016 |
| Days to Decision | 181 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FZE - Prosthesis, Nose, Internal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3680 |