MSA HIP SYSTEM

Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate

GLOBAL MANUFACTURING TECHNOLOGY

The following data is part of a premarket notification filed by Global Manufacturing Technology with the FDA for Msa Hip System.

Pre-market Notification Details

Device IDK102172
510k NumberK102172
Device Name:MSA HIP SYSTEM
ClassificationProsthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
Applicant GLOBAL MANUFACTURING TECHNOLOGY 1331 H STREET NW Washington,  DC  20005
ContactHollace S Rhodes
CorrespondentHollace S Rhodes
GLOBAL MANUFACTURING TECHNOLOGY 1331 H STREET NW Washington,  DC  20005
Product CodeMEH  
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-08-02
Decision Date2011-03-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
09348215087289 K102172 000
09348215087180 K102172 000
09348215087197 K102172 000
09348215087203 K102172 000
09348215087210 K102172 000
09348215087227 K102172 000
09348215087234 K102172 000
09348215087241 K102172 000
09348215087258 K102172 000
09348215087265 K102172 000
09348215087272 K102172 000
09348215087173 K102172 000

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