The following data is part of a premarket notification filed by Seaspine Orthopedics Corporation with the FDA for Seaspine Ventura Nanometalene System.
Device ID | K173022 |
510k Number | K173022 |
Device Name: | SeaSpine Ventura NanoMetalene System |
Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
Applicant | SeaSpine Orthopedics Corporation 5770 Armada Drive Carlsbad, CA 92008 |
Contact | Gina Flores |
Correspondent | Gina Flores SeaSpine Orthopedics Corporation 5770 Armada Drive Carlsbad, CA 92008 |
Product Code | MAX |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-09-28 |
Decision Date | 2017-10-26 |
Summary: | summary |