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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 K212636
Device Name CORUS Spinal System-X
Applicant
Providence Medical Technology, Inc.
4234 Hacienda Dr., Suite 150
Pleasanton,  CA  94588
Applicant Contact Edward Liou
Correspondent
Providence Medical Technology, Inc.
4234 Hacienda Dr., Suite 150
Pleasanton,  CA  94588
Correspondent Contact Edward Liou
Regulation Number888.1100
Classification Product Code
HRX  
Date Received08/19/2021
Decision Date 10/15/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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