FDA.reportPublic FDA data

GIZMO PRECISION MEDICAL LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30074068753007406875GIZMO PRECISION MEDICAL LLC1Y2020-04-256N343 Mission Hills Drive St Charles IL US 60175

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
992552035286715K173286Cannulated Screw Internal Fixation SystemHWC2017-12-14
992551847425561K172973Life Spine Foot and Ankle Plating SystemHRS2017-12-21
992551095930700K171448Hammertoe Correction SystemHWC2017-07-07
992551346355986K170919The TiBow Expandable Spacer SystemMAX2017-08-03
992551949644066K160066Pro-Link® Stand-Alone Cervical Spacer SystemOVE2016-09-02
992551697359274K153400ProLift Expandable SystemMAX2016-03-07
992551356402424K151196Nautilus Spinal SystemNKB2015-07-14
992551225802278K150368Tarsa-Link Wedge Fixation SystemHRS2015-03-24
992551031100124K142253SOLSTICE OCT SystemKWP2015-04-23
992551003852188K140236AILERON INTERSPINOUS FIXATION SYSTEMPEK2014-10-20
992551358913904K133717LONGBOW SPACER SYSTEMMAX2014-09-19
992551600758039K132589ANTERIOR LUMBAR PLATE SYSTEM (PRESIDIO)KWQ2013-10-08
992551788225559K130202IRIS ANTERIOR CERVICAL PLATEKWQ2013-04-29
992551316138694K113157AILERON INTERSPINOUS FIXATION SYSTEMMNI2012-03-13
992551896679655K111729PILOT SPINAL SYSTEMNKB2011-09-07
992551995401160K091301LIFE SPINE STAND-ALONE SPACER SYSTEMOVD2009-12-15
992551193491307K090865LIFE SPINE FACET SCREW SPINAL SYSTEMMRW2009-06-26
992551596403638K073479KINETIC-SL ANTERIOR CERVICAL PLATE SYSTEMKWQ2008-01-09

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MAX32017-08-03
KWQ32013-10-08
HRS22017-12-21
HWC22017-12-14
NKB22015-07-14
OVE12016-09-02
KWP12015-04-23
PEK12014-10-20
MNI12012-03-13
OVD12009-12-15
MRW12009-06-26