NEXTGEN ALTIUS OCT SYSTEM

Appliance, Fixation, Spinal Interlaminal

BIOMET SPINE (AKA EBI, LLC)

The following data is part of a premarket notification filed by Biomet Spine (aka Ebi, Llc) with the FDA for Nextgen Altius Oct System.

Pre-market Notification Details

Device IDK122378
510k NumberK122378
Device Name:NEXTGEN ALTIUS OCT SYSTEM
ClassificationAppliance, Fixation, Spinal Interlaminal
Applicant BIOMET SPINE (AKA EBI, LLC) 100 INTERPACE PARKWAY Parsippany,  NJ  07054
ContactVivian Kelly
CorrespondentVivian Kelly
BIOMET SPINE (AKA EBI, LLC) 100 INTERPACE PARKWAY Parsippany,  NJ  07054
Product CodeKWP  
Subsequent Product CodeMNH
Subsequent Product CodeMNI
CFR Regulation Number888.3050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-08-06
Decision Date2012-09-20
Summary:summary

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