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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer
510(k) Number K200151
Device Name Persona Partial Knee Tibial Cut Guide 5 Deg Left Medial Right Lateral, Persona Partial Knee Tibial Cut Guide 5 Deg Right Medial Left Lateral, Persona Partial Knee 2MM Tibial Recutter Left Medial Right Lateral, Persona Partial Knee 2MM Tibial Recutter Right Medial Left Lateral, Persona Partial Knee
Applicant
Zimmer, Inc.
1800 W. Center Street
Warsaw,  IN  46580
Applicant Contact Pankti Shah
Correspondent
Zimmer, Inc.
1800 W. Center Street
Warsaw,  IN  46580
Correspondent Contact Pankti Shah
Regulation Number888.3520
Classification Product Code
HSX  
Date Received01/22/2020
Decision Date 03/17/2020
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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