The following data is part of a premarket notification filed by Aju Pharm Co.,ltd. with the FDA for Joinix Cannular System.
| Device ID | K162070 |
| 510k Number | K162070 |
| Device Name: | JOINIX CANNULAR SYSTEM |
| Classification | Arthroscope |
| 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 Street Pittsburgh, PA 15213 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-27 |
| Decision Date | 2017-03-16 |
| Summary: | summary |