STRYKER SPINE OASYS SYSTEM

Orthosis, Spinal Pedicle Fixation

HOWMEDICA OSTEONICS CORP.

The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Stryker Spine Oasys System.

Pre-market Notification Details

Device IDK032394
510k NumberK032394
Device Name:STRYKER SPINE OASYS SYSTEM
ClassificationOrthosis, Spinal Pedicle Fixation
Applicant HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale,  NJ  07401 -1677
ContactKaren Ariemma
CorrespondentKaren Ariemma
HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale,  NJ  07401 -1677
Product CodeMNI  
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-08-04
Decision Date2004-02-20
Summary:summary

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