The following data is part of a premarket notification filed by Seaspine Orthopedics Corporation with the FDA for Seaspine Spacer System (nanometalene)- Hollywood, Hollywood Vi, Ventura, Pacifica; Seaspine Spacer System -hollywood, Hollywood Vi, Ventura, Pacifica; Seaspine Vu E·pod System.
| Device ID | K173260 |
| 510k Number | K173260 |
| Device Name: | SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica; SeaSpine Spacer System -Hollywood, Hollywood VI, Ventura, Pacifica; SeaSpine Vu E·POD 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-10 |
| Decision Date | 2017-12-04 |
| Summary: | summary |