SeaSpine Vu CPOD, Zuma-C, Complete Cervical

Intervertebral Fusion Device With Bone Graft, Cervical

SeaSpine Orthopedics Corporation

The following data is part of a premarket notification filed by Seaspine Orthopedics Corporation with the FDA for Seaspine Vu Cpod, Zuma-c, Complete Cervical.

Pre-market Notification Details

Device IDK172926
510k NumberK172926
Device Name:SeaSpine Vu CPOD, Zuma-C, Complete Cervical
ClassificationIntervertebral Fusion Device With Bone Graft, Cervical
Applicant SeaSpine Orthopedics Corporation 5770 Armada Drive Carlsbad,  CA  92008
ContactGina Flores
CorrespondentGina Flores
SeaSpine Orthopedics Corporation 5770 Armada Drive Carlsbad,  CA  92008
Product CodeODP  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-09-25
Decision Date2017-12-21
Summary:summary

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