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

Intervertebral Fusion Device With Bone Graft, Lumbar

SeaSpine Orthopedics Corporation

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.

Pre-market Notification Details

Device IDK210497
510k NumberK210497
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
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant SeaSpine Orthopedics Corporation 5770 Armada Drive Carlsbad,  CA  92008
ContactAly Alvarez
CorrespondentAly Alvarez
SeaSpine Orthopedics Corporation 5770 Armada Drive Carlsbad,  CA  92008
Product CodeMAX  
Subsequent Product CodeMQP
Subsequent Product CodeODP
Subsequent Product CodeOVD
Subsequent Product CodeOVE
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-22
Decision Date2021-07-07

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