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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, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer
510(k) Number K240299
Device Name Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)
Applicant
Zimmer, Inc.
1800 W. Center Street
Warsaw,  IN  46580
Applicant Contact Gregory Foster
Correspondent
Zimmer, Inc.
1800 W. Center Street
Warsaw,  IN  46580
Correspondent Contact Gregory Foster
Regulation Number888.3565
Classification Product Code
MBH  
Subsequent Product Codes
JWH   OIY  
Date Received02/01/2024
Decision Date 04/26/2024
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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