SeaSpine WaveForm™ A Interbody System

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 Waveform™ A Interbody System.

Pre-market Notification Details

Device IDK210583
510k NumberK210583
Device Name:SeaSpine WaveForm™ A Interbody System
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant SeaSpine Orthopedics Corporation 5770 Armada Drive Carlsbad,  CA  92008
ContactAly Alvarez
CorrespondentAlicia Mcarthur
SeaSpine Orthopedics Corporation 5770 Armada Drive Carlsbad,  CA  92008
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-26
Decision Date2021-06-02

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