The following data is part of a premarket notification filed by Southern Implants (pty) Ltd. with the FDA for Osseointegrated Fixtures.
| Device ID | K161548 |
| 510k Number | K161548 |
| Device Name: | Osseointegrated Fixtures |
| Classification | Prosthesis, Nose, Internal |
| Applicant | SOUTHERN IMPLANTS (PTY) LTD. 1 ALBERT STREET Centurion, ZA 0062 |
| Contact | Lauranda Breytenbach |
| Correspondent | E.j. Smith SMITH ASSOCIATES 1468 HARWELL AVENUE Crofton, MD 21114 |
| Product Code | FZE |
| CFR Regulation Number | 878.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-03 |
| Decision Date | 2016-12-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06009544028062 | K161548 | 000 |
| 06009544000655 | K161548 | 000 |
| 06009544000662 | K161548 | 000 |
| 06009544000679 | K161548 | 000 |
| 06009544000686 | K161548 | 000 |
| 06009544019824 | K161548 | 000 |
| 06009544000419 | K161548 | 000 |
| 06009544000426 | K161548 | 000 |
| 06009544000433 | K161548 | 000 |
| 06009544000440 | K161548 | 000 |
| 06009544000457 | K161548 | 000 |
| 06009544000464 | K161548 | 000 |
| 06009544011040 | K161548 | 000 |
| 06009544011057 | K161548 | 000 |
| 06009544011064 | K161548 | 000 |
| 06009544011071 | K161548 | 000 |
| 06009544021254 | K161548 | 000 |
| 06009544000648 | K161548 | 000 |