RADIUS SPINAL SYSTEM

Thoracolumbosacral Pedicle Screw System

STRYKER SPINE

The following data is part of a premarket notification filed by Stryker Spine with the FDA for Radius Spinal System.

Pre-market Notification Details

Device IDK062270
510k NumberK062270
Device Name:RADIUS SPINAL SYSTEM
ClassificationThoracolumbosacral Pedicle Screw System
Applicant STRYKER SPINE 2 PEARL COURT Allendale,  NJ  07401
ContactSimona Voic
CorrespondentSimona Voic
STRYKER SPINE 2 PEARL COURT Allendale,  NJ  07401
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 Received2006-08-07
Decision Date2006-11-22
Summary:summary

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