SeaSpine Orthopedics Corporation · Class II · Cleared Nov 25, 2020
| K-number | K201193 |
| Device name | SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu aPOD-L NanoMetalene; SeaSpine Vu ePOD System; and SeaSpine Reef TH System, SeaSpine Vu aPOD Prime NanoMetalene IBD; and SeaSpine Shoreline ACS, SeaSpine Cambria System; SeaSpine Regatta Lateral System; and SeaSpine Meridian System, Shoreline Cervical Interbody RT System; and SeaSpine Beachside System |
| Applicant | SeaSpine Orthopedics Corporation |
| Product code | MAX |
| Device class | Class II |
| Decision date | Nov 25, 2020 |
| Decision | Substantially Equivalent |
| Regulation | 888.3080 |
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