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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intraoperative Orthopedic Joint Assessment Aid
510(k) Number K200587
Device Name VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe Size 42 mm, LinkStation MINI, LinkStation MINI Evaluation Kit, VERASENSE Software Application for Shoulder
Applicant
Orthosensor, Inc.
1855 Griffin Rd. Suite A-310
Dania Beach,  FL  33004
Applicant Contact Deborah Escobar Johnson
Correspondent
Orthosensor, Inc.
1855 Griffin Rd. Suite A-310
Dania Beach,  FL  33004
Correspondent Contact Deborah Escobar Johnson
Regulation Number882.4560
Classification Product Code
ONN  
Date Received03/06/2020
Decision Date 08/25/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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