TILOCK PEDICLE SCREW SYSTEM

Thoracolumbosacral Pedicle Screw System

GENESYS SPINE

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

Pre-market Notification Details

Device IDK100757
510k NumberK100757
Device Name:TILOCK PEDICLE SCREW SYSTEM
ClassificationThoracolumbosacral Pedicle Screw System
Applicant GENESYS SPINE 1250 CAPITAL OF TEXAS HWY SO. BUILDING THREE, SUITE 600 Austin,  TX  78746
ContactJosh Kaufmann
CorrespondentJosh Kaufmann
GENESYS SPINE 1250 CAPITAL OF TEXAS HWY SO. BUILDING THREE, SUITE 600 Austin,  TX  78746
Product CodeNKB  
Subsequent Product CodeMNH
Subsequent Product CodeMNI
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-03-17
Decision Date2010-07-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
M719G1501050 K100757 000
M719GL3130 K100757 000
M719GL3120 K100757 000
M719GL3100 K100757 000
M719GL2240 K100757 000
M719GL2220 K100757 000
M719GL217NC0 K100757 000
M719GL212NC0 K100757 000
M719GL201TIB0 K100757 000
M719G00020 K100757 000
M719G00010 K100757 000
M719G00000 K100757 000
M71930051400 K100757 000
M71930051300 K100757 000
M719GL3150 K100757 000
M719GL4210 K100757 000
M719GLC4780 K100757 000
M719GLC4660 K100757 000
M719GLC4630 K100757 000
M719GLC4620 K100757 000
M719GLC46110 K100757 000
M719GLC4600 K100757 000
M719GLC4590 K100757 000
M719GLC453R0 K100757 000
M719GLC453L0 K100757 000
M719GLC452R0 K100757 000
M719GLC452L0 K100757 000
M719GLC42510 K100757 000
M719GLC409850 K100757 000
M719SPGL2110 K100757 000

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