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 |