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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name orthopedic stereotaxic instrument
510(k) Number K183381
Device Name Navigation Enabled Instruments
Applicant
STRYKER
2 Pearl Court
allendale,  NJ  07401
Applicant Contact megan callanan
Correspondent
STRYKER
2 Pearl Court
allendale,  NJ  07401
Correspondent Contact megan callanan
Regulation Number882.4560
Classification Product Code
OLO  
Date Received12/06/2018
Decision Date 05/17/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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