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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 K193580
Device Name VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right, VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Left
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  
Subsequent Product Code
OLO  
Date Received12/23/2019
Decision Date 04/01/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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