The following data is part of a premarket notification filed by Seaspine Orthopedics Corporation with the FDA for Seaspine Vu A•pod Prime Nanometalene Intervertebral Body Fusion Device, Seaspine Vu A•pod Prime Intervertebral Body Fusion Device.
| Device ID | K173606 |
| 510k Number | K173606 |
| Device Name: | SeaSpine Vu A•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu A•POD Prime Intervertebral Body Fusion Device |
| Classification | Intervertebral Fusion Device With Integrated Fixation, 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 | OVD |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-21 |
| Decision Date | 2018-04-13 |
| Summary: | summary |