POLARIS SPINAL SYSTEM

Thoracolumbosacral Pedicle Screw System

BIOMET SPINE (EBI LLC)

The following data is part of a premarket notification filed by Biomet Spine (ebi Llc) with the FDA for Polaris Spinal System.

Pre-market Notification Details

Device IDK111957
510k NumberK111957
Device Name:POLARIS SPINAL SYSTEM
ClassificationThoracolumbosacral Pedicle Screw System
Applicant BIOMET SPINE (EBI LLC) 100 INTERPACE PARKWAY Parsippany,  NJ  07540
ContactVivian Kelly, Rac
CorrespondentVivian Kelly, Rac
BIOMET SPINE (EBI LLC) 100 INTERPACE PARKWAY Parsippany,  NJ  07540
Product CodeNKB  
Subsequent Product CodeKWP
Subsequent Product CodeKWQ
Subsequent Product CodeMNH
Subsequent Product CodeMNI
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-07-11
Decision Date2011-08-19
Summary:summary

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