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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
510(k) Number K180973
Device Name Libertas Hip Replacement System
Applicant
Maxx Orthopedics, Inc.
531 Plymouth Rd., Suite 526
Plymouth Meeting,  PA  19462
Applicant Contact Corey Perine
Correspondent
Musculoskeltal Clinical Regulatory Advisors, LLC
1050 K. St. NW
Suite 1000
Washington,  DC  20001
Correspondent Contact Hollace Saas Rhodes
Regulation Number888.3350
Classification Product Code
JDI  
Subsequent Product Code
LZO  
Date Received04/13/2018
Decision Date 09/28/2018
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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