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 |