WaveForm L System, WaveForm TO System, WaveForm TA 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 Waveform L System, Waveform To System, Waveform Ta System.

Pre-market Notification Details

Device IDK213420
510k NumberK213420
Device Name:WaveForm L System, WaveForm TO System, WaveForm TA System
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant SeaSpine Orthopedics Corporation 5770 Armada Drive Carlsbad,  CA  92008
ContactAly Alvarez
CorrespondentJesse Albright
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 Received2021-10-20
Decision Date2022-05-04

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