The following data is part of a premarket notification filed by Aju Pharm Co., Ltd. with the FDA for Fixone Biocomposite Anchor.
| Device ID | K192484 |
| 510k Number | K192484 |
| Device Name: | Fixone Biocomposite Anchor |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | AJU Pharm Co., Ltd. A-207, 697, Pangyo-ro Seongnam-si, KR 13511 |
| Contact | Kim Jung Gil |
| Correspondent | Peter Chung Plus Global 300 Atwood Pittsburgh, PA 15213 |
| Product Code | MAI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-10 |
| Decision Date | 2020-03-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850005827252 | K192484 | 000 |
| 00850005827245 | K192484 | 000 |
| 00850005827238 | K192484 | 000 |
| 00850005827221 | K192484 | 000 |
| 00850005827214 | K192484 | 000 |