U & I AMERICA SPINAL HOOK SYSTEM

Appliance, Fixation, Spinal Interlaminal

U&I CORP., AMERICA

The following data is part of a premarket notification filed by U&i Corp., America with the FDA for U & I America Spinal Hook System.

Pre-market Notification Details

Device IDK031595
510k NumberK031595
Device Name:U & I AMERICA SPINAL HOOK SYSTEM
ClassificationAppliance, Fixation, Spinal Interlaminal
Applicant U&I CORP., AMERICA 6132 SOUTH 380 WEST, SUITE 200 Murray,  UT  84107 -6988
ContactPatrick Moore
CorrespondentPatrick Moore
U&I CORP., AMERICA 6132 SOUTH 380 WEST, SUITE 200 Murray,  UT  84107 -6988
Product CodeKWP  
CFR Regulation Number888.3050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-05-21
Decision Date2003-06-24
Summary:summary

NIH GUDID Devices

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