The following data is part of a premarket notification filed by Medyssey Co., Ltd. with the FDA for Medyssey Cannulated Pedicle Screw.
| Device ID | K121670 |
| 510k Number | K121670 |
| Device Name: | MEDYSSEY CANNULATED PEDICLE SCREW |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | MEDYSSEY CO., LTD. 8001 N. LINCOLN AVE SUITE 401 Skokie, IL 60077 |
| Contact | Michael Kvitnitsky |
| Correspondent | Michael Kvitnitsky MEDYSSEY CO., LTD. 8001 N. LINCOLN AVE SUITE 401 Skokie, IL 60077 |
| Product Code | NKB |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-06 |
| Decision Date | 2013-01-25 |
| Summary: | summary |