The following data is part of a premarket notification filed by Aju Pharm Co., Ltd. with the FDA for Fixone Hybrid Knotless Anchor.
| Device ID | K203523 |
| 510k Number | K203523 |
| Device Name: | Fixone Hybrid Knotless Anchor |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | AJU Pharm Co., Ltd. A-207, 697, Pangyo-ro Seongnam-si, KR 13511 |
| Contact | Kim Tae Hoon |
| Correspondent | Peter Chung Plus Global 300 Atwood Pittsburgh, PA 15213 |
| Product Code | MAI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-01 |
| Decision Date | 2021-12-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850005827283 | K203523 | 000 |
| 00850005827276 | K203523 | 000 |
| 00850005827382 | K203523 | 000 |
| 08800039102254 | K203523 | 000 |
| 08800039102216 | K203523 | 000 |
| 08800039101035 | K203523 | 000 |
| 08800039101028 | K203523 | 000 |
| 08800039100601 | K203523 | 000 |
| 08800039100571 | K203523 | 000 |