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 |