VIA SPINOUS PROCESS FIXATION SYSTEM

Spinous Process Plate

SPINEOLOGY, INC.

The following data is part of a premarket notification filed by Spineology, Inc. with the FDA for Via Spinous Process Fixation System.

Pre-market Notification Details

Device IDK142213
510k NumberK142213
Device Name:VIA SPINOUS PROCESS FIXATION SYSTEM
ClassificationSpinous Process Plate
Applicant SPINEOLOGY, INC. 7800 3RD STREET NORTH Saint Paul,  MN  55128
ContactTim Crabtree
CorrespondentTim Crabtree
SPINEOLOGY, INC. 7800 3RD STREET NORTH Saint Paul,  MN  55128
Product CodePEK  
CFR Regulation Number888.3050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-08-12
Decision Date2014-09-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
M7404400046 K142213 000
M7404400022 K142213 000
M7404400021 K142213 000
M7404400020 K142213 000
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M7404400006 K142213 000
M7404400005 K142213 000
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M7404400003 K142213 000
M7404400002 K142213 000
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M7404400024 K142213 000
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M7404400041 K142213 000
M7404400040 K142213 000
M7404400039 K142213 000
M7404400038 K142213 000
M7404400037 K142213 000
M7404400036 K142213 000
M7404400035 K142213 000
M7404400034 K142213 000
M7404400033 K142213 000
M7404400032 K142213 000
M7404400030 K142213 000
M7404400028 K142213 000
M7404400027 K142213 000
M7404400026 K142213 000
M7404400001 K142213 000

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