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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 K180459
Device Name VERASENSE for Zimmer Biomet Persona
Applicant
OrthoSensor, Inc.
1855 Griffin Road, Suite A-310
Dania Beach,  FL  33004
Applicant Contact Deborah Johnson
Correspondent
OrthoSensor, Inc.
1855 Griffin Road, Suite A-310
Dania Beach,  FL  33004
Correspondent Contact Deborah Johnson
Regulation Number882.4560
Classification Product Code
ONN  
Date Received02/20/2018
Decision Date 06/07/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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