FIXION HIP SYSTEM

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

DISC-O-TECH MEDICAL TECHNOLOGIES, LTD.

The following data is part of a premarket notification filed by Disc-o-tech Medical Technologies, Ltd. with the FDA for Fixion Hip System.

Pre-market Notification Details

Device IDK032730
510k NumberK032730
Device Name:FIXION HIP SYSTEM
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Applicant DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. 3 HASADNAOT Herzelia,  IL 46728
ContactHila Wachsler-avrahami
CorrespondentHila Wachsler-avrahami
DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. 3 HASADNAOT Herzelia,  IL 46728
Product CodeJDI  
Subsequent Product CodeJDG
Subsequent Product CodeKWL
Subsequent Product CodeLPH
Subsequent Product CodeLWJ
Subsequent Product CodeMBL
CFR Regulation Number888.3350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-09-03
Decision Date2004-03-26
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.