Libertas Hip Replacement System

Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

Maxx Orthopedics, Inc

The following data is part of a premarket notification filed by Maxx Orthopedics, Inc with the FDA for Libertas Hip Replacement System.

Pre-market Notification Details

Device IDK180973
510k NumberK180973
Device Name:Libertas Hip Replacement System
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Applicant Maxx Orthopedics, Inc 531 Plymouth Road, Suite 526 Plymouth Meeting,  PA  19462
ContactCorey Perine
CorrespondentHollace Saas Rhodes
Musculoskeltal Clinical Regulatory Advisors, LLC 1050 K Street NW Suite 1000 Washington,  DC  20001
Product CodeJDI  
CFR Regulation Number888.3350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-04-13
Decision Date2018-09-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00810008121887 K180973 000
00810008121870 K180973 000
00810008121863 K180973 000
00810008121856 K180973 000
00810008121849 K180973 000
00810008121832 K180973 000
00810008121825 K180973 000
00810008121818 K180973 000

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