SeaSpine Reef TH 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 Reef Th System.

Pre-market Notification Details

Device IDK193636
510k NumberK193636
Device Name:SeaSpine Reef TH System
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant SeaSpine Orthopedics Corporation 5770 Armada Drive Carlsbad,  CA  98008
ContactAly Alvarez
CorrespondentAly Alvarez
SeaSpine Orthopedics Corporation 5770 Armada Drive Carlsbad,  CA  98008
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-27
Decision Date2020-04-24

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