ZIMMER POROLOCK MIS STEM

Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component)

ZIMMER GMBH

The following data is part of a premarket notification filed by Zimmer Gmbh with the FDA for Zimmer Porolock Mis Stem.

Pre-market Notification Details

Device IDK071723
510k NumberK071723
Device Name:ZIMMER POROLOCK MIS STEM
ClassificationProsthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component)
Applicant ZIMMER GMBH P.O. BOX 708 Warsaw,  IN  46581 -0708
ContactDalene T Binkley
CorrespondentDalene T Binkley
ZIMMER GMBH P.O. BOX 708 Warsaw,  IN  46581 -0708
Product CodeKWA  
Subsequent Product CodeJDI
Subsequent Product CodeJDL
Subsequent Product CodeKWL
Subsequent Product CodeKWY
Subsequent Product CodeKWZ
Subsequent Product CodeLWJ
Subsequent Product CodeLZO
CFR Regulation Number888.3330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-06-25
Decision Date2008-03-07
Summary:summary

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