SeaSpine Meridian System, SeaSpine Regatta Lateral 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 Meridian System, Seaspine Regatta Lateral System.

Pre-market Notification Details

Device IDK200879
510k NumberK200879
Device Name:SeaSpine Meridian System, SeaSpine Regatta Lateral System
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant SeaSpine Orthopedics Corporation 5770 Armada Drive Carlsbad,  CA  92008
ContactAly Alvarez
CorrespondentAly Alvarez
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 Received2020-04-02
Decision Date2020-06-10

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.