Seaspine WaveForm C Interbody System

Intervertebral Fusion Device With Integrated Fixation, Cervical

SeaSpine Orthopedics Corporation

The following data is part of a premarket notification filed by Seaspine Orthopedics Corporation with the FDA for Seaspine Waveform C Interbody System.

Pre-market Notification Details

Device IDK201073
510k NumberK201073
Device Name:Seaspine WaveForm C Interbody System
ClassificationIntervertebral Fusion Device With Integrated Fixation, Cervical
Applicant SeaSpine Orthopedics Corporation 5770 Armada Drive Carlsbad,  CA  92008
ContactAly Alvarez
CorrespondentAly Alvarez
SeaSpine Orthopedics Corporation 5770 Armada Drive Carlsbad,  CA  92008
Product CodeOVE  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-22
Decision Date2020-09-18

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