TRIO PLATE SYSTEM, TRIO SPINAL FIXATION SYSTEM, TRIO+ SPINAL SYSTEM

Thoracolumbosacral Pedicle Screw System

STRYKER CORP.

The following data is part of a premarket notification filed by Stryker Corp. with the FDA for Trio Plate System, Trio Spinal Fixation System, Trio+ Spinal System.

Pre-market Notification Details

Device IDK070368
510k NumberK070368
Device Name:TRIO PLATE SYSTEM, TRIO SPINAL FIXATION SYSTEM, TRIO+ SPINAL SYSTEM
ClassificationThoracolumbosacral Pedicle Screw System
Applicant STRYKER CORP. 2 PEARL COURT Allendale,  NJ  07401
ContactSimona Voic
CorrespondentSimona Voic
STRYKER CORP. 2 PEARL COURT Allendale,  NJ  07401
Product CodeNKB  
Subsequent Product CodeMNH
Subsequent Product CodeMNI
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-02-08
Decision Date2007-05-04
Summary:summary

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