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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arthroscope
510(k) Number K190201
Device Name CORUS Spinal System
Applicant
Providence Medical Technology, Inc.
3875 Hopyard Rd.
Suite 300
Pleasanton,  CA  94588
Applicant Contact Janie Mandrusov
Correspondent
Providence Medical Technology, Inc.
3875 Hopyard Rd.
Suite 300
Pleasanton,  CA  94588
Correspondent Contact Janie Mandrusov
Regulation Number888.1100
Classification Product Code
HRX  
Date Received02/04/2019
Decision Date 03/08/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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