ISSYS LP SPINAL FIXATION SYSTEM

Thoracolumbosacral Pedicle Screw System

CUSTOM SPINE, INC.

The following data is part of a premarket notification filed by Custom Spine, Inc. with the FDA for Issys Lp Spinal Fixation System.

Pre-market Notification Details

Device IDK111099
510k NumberK111099
Device Name:ISSYS LP SPINAL FIXATION SYSTEM
ClassificationThoracolumbosacral Pedicle Screw System
Applicant CUSTOM SPINE, INC. 1140 PARSIPPANY BLVD. SUITE 201 Parsippany,  NJ  07054
ContactSaad Attiyah
CorrespondentSaad Attiyah
CUSTOM SPINE, INC. 1140 PARSIPPANY BLVD. SUITE 201 Parsippany,  NJ  07054
Product CodeNKB  
Subsequent Product CodeKWP
Subsequent Product CodeKWQ
Subsequent Product CodeMNH
Subsequent Product CodeMNI
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-04-20
Decision Date2011-05-05
Summary:summary

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