CORAL PEDICLE SCREW SYSTEM

Thoracolumbosacral Pedicle Screw System

THEKEN SPINE LLC

The following data is part of a premarket notification filed by Theken Spine Llc with the FDA for Coral Pedicle Screw System.

Pre-market Notification Details

Device IDK070962
510k NumberK070962
Device Name:CORAL PEDICLE SCREW SYSTEM
ClassificationThoracolumbosacral Pedicle Screw System
Applicant THEKEN SPINE LLC 283 E WATERLOO RD. Akron,  OH  44319
ContactDale Davison
CorrespondentDale Davison
THEKEN SPINE LLC 283 E WATERLOO RD. Akron,  OH  44319
Product CodeNKB  
Subsequent Product CodeKWP
Subsequent Product CodeKWQ
Subsequent Product CodeMNH
Subsequent Product CodeMNI
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-04-05
Decision Date2007-08-22
Summary:summary

NIH GUDID Devices

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