OASYS SPINAL SYSTEM

Appliance, Fixation, Spinal Interlaminal

STRYKER SPINE

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

Pre-market Notification Details

Device IDK111719
510k NumberK111719
Device Name:OASYS SPINAL SYSTEM
ClassificationAppliance, Fixation, Spinal Interlaminal
Applicant STRYKER SPINE 2 PEARL COURT Allendale,  NJ  07401
ContactSoraya King
CorrespondentSoraya King
STRYKER SPINE 2 PEARL COURT Allendale,  NJ  07401
Product CodeKWP  
CFR Regulation Number888.3050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-06-20
Decision Date2012-01-19
Summary:summary

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