TOWERLOX PEDICLE SCREW SYSTEM

Orthosis, Spinal Pedicle Fixation

CAPTIVA SPINE

The following data is part of a premarket notification filed by Captiva Spine with the FDA for Towerlox Pedicle Screw System.

Pre-market Notification Details

Device IDK122332
510k NumberK122332
Device Name:TOWERLOX PEDICLE SCREW SYSTEM
ClassificationOrthosis, Spinal Pedicle Fixation
Applicant CAPTIVA SPINE 13540 GUILD AVE Apple Vally,  MN  55124
ContactRich Jansen
CorrespondentRich Jansen
CAPTIVA SPINE 13540 GUILD AVE Apple Vally,  MN  55124
Product CodeMNI  
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-08-02
Decision Date2012-10-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
M739161554120 K122332 000
M739161554035 K122332 000
M739161554045 K122332 000
M739161554050 K122332 000
M739161554055 K122332 000
M739161554060 K122332 000
M739161554065 K122332 000
M739161554070 K122332 000
M739161554075 K122332 000
M739161554080 K122332 000
M739161554085 K122332 000
M739161554090 K122332 000
M739161554110 K122332 000
M739161554030 K122332 000

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