OASYS System

Appliance, Fixation, Spinal Interlaminal

STRYKER CORPORATION

The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Oasys System.

Pre-market Notification Details

Device IDK142741
510k NumberK142741
Device Name:OASYS System
ClassificationAppliance, Fixation, Spinal Interlaminal
Applicant STRYKER CORPORATION 2 PEARL COURT Allendale,  NJ  07401
ContactGarry T Hayeck
CorrespondentGarry T Hayeck
STRYKER CORPORATION 2 PEARL COURT Allendale,  NJ  07401
Product CodeKWP  
CFR Regulation Number888.3050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-09-24
Decision Date2015-01-15
Summary:summary

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