SeaSpine Orthopedics Corporation · Class II · Cleared Jul 7, 2021
| K-number | K210497 |
| Device name | SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu aPOD-L NanoMetalene, SeaSpine Vu ePOD System, SeaSpine Vu aPOD Prime NanoMetalene Intervertebral, SeaSpine Shoreline ACS - Anterior Cervical Standalone, SeaSpine Cervical Interbody RT System, SeaSpine Cambria System, SeaSpine Regatta Lateral System, SeaSpine Reef TO/TA System, SeaSpine Reef TH System, SeaSpine Meridian System |
| Applicant | SeaSpine Orthopedics Corporation |
| Product code | MAX |
| Device class | Class II |
| Decision date | Jul 7, 2021 |
| Decision | Substantially Equivalent |
| Regulation | 888.3080 |
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