SeaSpine Vu A•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu A•POD Prime Intervertebral Body Fusion Device

Intervertebral Fusion Device With Integrated Fixation, Lumbar

SeaSpine Orthopedics Corporation

The following data is part of a premarket notification filed by Seaspine Orthopedics Corporation with the FDA for Seaspine Vu A•pod Prime Nanometalene Intervertebral Body Fusion Device, Seaspine Vu A•pod Prime Intervertebral Body Fusion Device.

Pre-market Notification Details

Device IDK173606
510k NumberK173606
Device Name:SeaSpine Vu A•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu A•POD Prime Intervertebral Body Fusion Device
ClassificationIntervertebral Fusion Device With Integrated Fixation, Lumbar
Applicant SeaSpine Orthopedics Corporation 5770 Armada Drive Carlsbad,  CA  92008
ContactGina Flores
CorrespondentGina Flores
SeaSpine Orthopedics Corporation 5770 Armada Drive Carlsbad,  CA  92008
Product CodeOVD  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-11-21
Decision Date2018-04-13
Summary:summary

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