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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/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
510(k) Number K183365
Device Name Libertas Acetabular Hooded Liner
Applicant
Maxx Orthopedics, Inc.
2460 General Armistead Ave. Suite 100
Norristown,  PA  19403
Applicant Contact Priscilla Herpai
Correspondent
Maxx Orthopedics, Inc.
2460 General Armistead Ave. Suite 100
Norristown,  PA  19403
Correspondent Contact Priscilla Herpai
Regulation Number888.3353
Classification Product Code
LZO  
Date Received12/04/2018
Decision Date 02/22/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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