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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 K150680
Device Name Freedom Cementless Femoral Component
Applicant
Maxx Orthopedics, Inc.
531 Plymouth Rd., Suite 526
Plymouth Meeting,  PA  19462
Applicant Contact Gabriela Gottlieb
Correspondent
Maxx Orthopedics, Inc.
531 Plymouth Rd., Suite 526
Plymouth Meeting,  PA  19462
Correspondent Contact Gabriela Gottlieb
Regulation Number888.3565
Classification Product Code
MBH  
Date Received03/17/2015
Decision Date 06/26/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
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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