The following data is part of a premarket notification filed by Medyssey Usa, Inc. with the FDA for Taurus Peek Cage System.
| Device ID | K170389 |
| 510k Number | K170389 |
| Device Name: | TAURUS PEEK Cage System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Medyssey USA, Inc. 1550 East Higgins Road, Suite 123 Elk Grove Village, IL 60007 |
| Contact | Shawn Kim |
| Correspondent | Christine Scifert MRC-X, LLC 6075 Poplar Ave, Suite 500 Memphis, TN 38119 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-08 |
| Decision Date | 2017-12-14 |
| Summary: | summary |