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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, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
510(k) Number K111785
Device Name FREEDOM(R) STEMMED TIBIAL COMPONENTS
Applicant
Maxx Orthopedics, Inc.
2260 Butler Pike, Suite 100
Plymouth Meeting,  PA  19462
Applicant Contact NACHE DAVE
Correspondent
Maxx Orthopedics, Inc.
2260 Butler Pike, Suite 100
Plymouth Meeting,  PA  19462
Correspondent Contact NACHE DAVE
Regulation Number888.3560
Classification Product Code
JWH  
Date Received06/24/2011
Decision Date 06/29/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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