Reform Pedicle Screw System

Thoracolumbosacral Pedicle Screw System

PRECISION SPINE, INC.

The following data is part of a premarket notification filed by Precision Spine, Inc. with the FDA for Reform Pedicle Screw System.

Pre-market Notification Details

Device IDK143248
510k NumberK143248
Device Name:Reform Pedicle Screw System
ClassificationThoracolumbosacral Pedicle Screw System
Applicant PRECISION SPINE, INC. 5 SYLVAN WAY SUITE 220 Parsippany,  NJ  07054
ContactMichael C. Dawson
CorrespondentKenneth C. Maxwell
EMPIRICAL CONSULTING, LLC 4628 NORTHPARK DRIVE Colorado Springs,  CO  80918
Product CodeNKB  
Subsequent Product CodeKWP
Subsequent Product CodeMNH
Subsequent Product CodeMNI
Subsequent Product CodeOSH
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-11-12
Decision Date2014-12-19
Summary:summary

NIH GUDID Devices

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