SPINAL USA ANTERIOR LUMBAR PLATE SYSTEM

Appliance, Fixation, Spinal Intervertebral Body

SPINAL USA

The following data is part of a premarket notification filed by Spinal Usa with the FDA for Spinal Usa Anterior Lumbar Plate System.

Pre-market Notification Details

Device IDK091044
510k NumberK091044
Device Name:SPINAL USA ANTERIOR LUMBAR PLATE SYSTEM
ClassificationAppliance, Fixation, Spinal Intervertebral Body
Applicant SPINAL USA 2050 EXECUTIVE DR. Pearl,  MS  39208
ContactJefferey Johnson
CorrespondentJefferey Johnson
SPINAL USA 2050 EXECUTIVE DR. Pearl,  MS  39208
Product CodeKWQ  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-04-13
Decision Date2009-07-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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00840019912594 K091044 000
00840019912587 K091044 000
00840019936910 K091044 000

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