Captiva Spine And CapLOX II/TowerLOX Pedicle Screw System

Orthosis, Spondylolisthesis Spinal Fixation

Captiva Spine

The following data is part of a premarket notification filed by Captiva Spine with the FDA for Captiva Spine And Caplox Ii/towerlox Pedicle Screw System.

Pre-market Notification Details

Device IDK160020
510k NumberK160020
Device Name:Captiva Spine And CapLOX II/TowerLOX Pedicle Screw System
ClassificationOrthosis, Spondylolisthesis Spinal Fixation
Applicant Captiva Spine 967 N. Alternate A1A Ste 1 Jupiter,  FL  33477
ContactTamala J. Wampler
CorrespondentKennneth C. Maxwell
Empirical Testing Corp. 4628 Northpark Drive Colorado Springs,  CO  80918
Product CodeMNH  
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-01-05
Decision Date2016-03-02
Summary:summary

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