POWER ADAPTOR INSTRUMENT ACCESSORY

Thoracolumbosacral Pedicle Screw System

STRYKER CORP.

The following data is part of a premarket notification filed by Stryker Corp. with the FDA for Power Adaptor Instrument Accessory.

Pre-market Notification Details

Device IDK120434
510k NumberK120434
Device Name:POWER ADAPTOR INSTRUMENT ACCESSORY
ClassificationThoracolumbosacral Pedicle Screw System
Applicant STRYKER CORP. 2 PEARL COURT Allendale,  NJ  07401
ContactTiffani Rogers
CorrespondentTiffani Rogers
STRYKER CORP. 2 PEARL COURT Allendale,  NJ  07401
Product CodeNKB  
Subsequent Product CodeMNH
Subsequent Product CodeMNI
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-02-13
Decision Date2012-03-08
Summary:summary

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