Resorbable Mesh Pouch (Ballast MT, OsteoBallast MT)

Filler, Bone Void, Osteoinduction (w/o Human Growth Factor)

SeaSpine Orthopedics Corporation

The following data is part of a premarket notification filed by Seaspine Orthopedics Corporation with the FDA for Resorbable Mesh Pouch (ballast Mt, Osteoballast Mt).

Pre-market Notification Details

Device IDK200290
510k NumberK200290
Device Name:Resorbable Mesh Pouch (Ballast MT, OsteoBallast MT)
ClassificationFiller, Bone Void, Osteoinduction (w/o Human Growth Factor)
Applicant SeaSpine Orthopedics Corporation 2 Goodyear Irvine,  CA  92618
ContactCaryn Sailor
CorrespondentCaryn Sailor
SeaSpine Orthopedics Corporation 2 Goodyear Irvine,  CA  92618
Product CodeMBP  
CFR Regulation Number888.3045 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-05
Decision Date2020-05-11

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