The following data is part of a premarket notification filed by Medyssey Usa, Inc. with the FDA for Triton Cage.
Device ID | K183407 |
510k Number | K183407 |
Device Name: | Triton Cage |
Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
Applicant | Medyssey USA, Inc. 1550 E. Higgins Road, Suite 123 Elk Grove Village, IL 60007 |
Contact | Shawn Kim |
Correspondent | Justin Eggleton Musculoskeletal Clinical Regulatory Advisers, LLC 1050 K Street NW, Suite 1000 Washington, DC 20001 |
Product Code | MAX |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-12-10 |
Decision Date | 2019-08-30 |