The following data is part of a premarket notification filed by Seaspine Orthopedics Corporation with the FDA for Seaspine Spacer System Nm (hollywood, Hollywood Vi, Pacifica, Redondo, Ventura), Vu A•pod-l Nanometalene, Seaspine Vu E•pod System, Seaspine Vu A•pod Prime Nanometalene Intervertebral, Seaspine Shoreline Acs - Anterior Cervical Standalone, Seaspine C.
| Device ID | K210497 |
| 510k Number | K210497 |
| Device Name: | SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu A•POD-L NanoMetalene, SeaSpine Vu E•POD System, SeaSpine Vu A•POD Prime NanoMetalene Intervertebral, SeaSpine Shoreline ACS - Anterior Cervical Standalone, SeaSpine C |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | SeaSpine Orthopedics Corporation 5770 Armada Drive Carlsbad, CA 92008 |
| Contact | Aly Alvarez |
| Correspondent | Aly Alvarez SeaSpine Orthopedics Corporation 5770 Armada Drive Carlsbad, CA 92008 |
| Product Code | MAX |
| Subsequent Product Code | MQP |
| Subsequent Product Code | ODP |
| Subsequent Product Code | OVD |
| Subsequent Product Code | OVE |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-22 |
| Decision Date | 2021-07-07 |