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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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