The following data is part of a premarket notification filed by Medyssey Usa, Inc. with the FDA for Poseidon Oct Spinal Fixation System.
| Device ID | K161637 |
| 510k Number | K161637 |
| Device Name: | Poseidon OCT Spinal Fixation System |
| Classification | Posterior Cervical Screw System |
| Applicant | Medyssey USA, Inc. 1550 E. Higgins Road, Suite 123 Elk Grove Village, IL 60007 |
| Contact | Shawn Kim |
| Correspondent | Rich Jansen, Pharm.d. Silver Pine Consulting, LLC. 11821 Bramble Cove Drive Fort Myers, FL 33905 |
| Product Code | NKG |
| CFR Regulation Number | 888.3075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-14 |
| Decision Date | 2017-01-05 |
| Summary: | summary |