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; And Seaspine Reef Th System, Seaspine Vu A•pod Prime Nanometalene Ibd; And Seaspine Shoreline Acs, Seaspine Cambria Sy.
| Device ID | K201193 |
| 510k Number | K201193 |
| Device Name: | SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu A•POD-L NanoMetalene; SeaSpine Vu E•POD System; And SeaSpine Reef TH System, SeaSpine Vu A•POD Prime NanoMetalene IBD; And SeaSpine Shoreline ACS, SeaSpine Cambria Sy |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | SeaSpine Orthopedics Corporation 5770 Armada Drive Carlsbad, CA 92008 |
| Contact | Alicia Mcarthur |
| Correspondent | Jesse Albright 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-04 |
| Decision Date | 2020-11-25 |