Resorbable Mesh Device

Filler, Bone Void, Calcium Compound

SeaSpine Orthopedics Corporation

The following data is part of a premarket notification filed by Seaspine Orthopedics Corporation with the FDA for Resorbable Mesh Device.

Pre-market Notification Details

Device IDK172130
510k NumberK172130
Device Name:Resorbable Mesh Device
ClassificationFiller, Bone Void, Calcium Compound
Applicant SeaSpine Orthopedics Corporation 2 Goodyear Irvine,  CA  92618
ContactJenny Fam
CorrespondentCaryn Sailor
SeaSpine Orthopedics Corporation 5770 Armada Drive Carlsbad,  CA  98008
Product CodeMQV  
CFR Regulation Number888.3045 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-07-14
Decision Date2017-11-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10889981149376 K172130 000
10889981149369 K172130 000
10889981149352 K172130 000
10889981149345 K172130 000
10889981149338 K172130 000
10889981149321 K172130 000
10889981149314 K172130 000
10889981149307 K172130 000

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