MANTIS SPINAL SYSTEM & MANTIS REDUX 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 Mantis Spinal System & Mantis Redux Spinal System.

Pre-market Notification Details

Device IDK102235
510k NumberK102235
Device Name:MANTIS SPINAL SYSTEM & MANTIS REDUX SPINAL SYSTEM
ClassificationThoracolumbosacral Pedicle Screw System
Applicant STRYKER SPINE 2 PEARL COURT Allendale,  NJ  07401
ContactCurtis Truesdale
CorrespondentCurtis Truesdale
STRYKER SPINE 2 PEARL COURT Allendale,  NJ  07401
Product CodeNKB  
Subsequent Product CodeKWQ
Subsequent Product CodeMNH
Subsequent Product CodeMNI
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-08-09
Decision Date2010-08-24
Summary:summary

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