Seneka II Polyscrew Pedicle Fixation System

Thoracolumbosacral Pedicle Screw System

Senecka Spine

The following data is part of a premarket notification filed by Senecka Spine with the FDA for Seneka Ii Polyscrew Pedicle Fixation System.

Pre-market Notification Details

Device IDK153525
510k NumberK153525
Device Name:Seneka II Polyscrew Pedicle Fixation System
ClassificationThoracolumbosacral Pedicle Screw System
Applicant Senecka Spine 46 Harrison Street Johnson City,  NY  13790
ContactKhalid Sethi
CorrespondentRich Jansen
SILVER PINE CONSULTING, LLC. 11821 BRAMBLE COVE DRIVE Fort Myers,  FL  33905
Product CodeNKB  
Subsequent Product CodeKWP
Subsequent Product CodeKWQ
Subsequent Product CodeMNH
Subsequent Product CodeMNI
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-12-09
Decision Date2016-01-28

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