MODULAR-PLUS REVISION STEM

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

PLUS ORTHOPEDICS

The following data is part of a premarket notification filed by Plus Orthopedics with the FDA for Modular-plus Revision Stem.

Pre-market Notification Details

Device IDK994126
510k NumberK994126
Device Name:MODULAR-PLUS REVISION STEM
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Uncemented
Applicant PLUS ORTHOPEDICS 3550 GENERAL ATOMICS CT. BLDG. 15-100 San Diego,  CA  92121 -1194
ContactHartmut Loch
CorrespondentHartmut Loch
PLUS ORTHOPEDICS 3550 GENERAL ATOMICS CT. BLDG. 15-100 San Diego,  CA  92121 -1194
Product CodeLWJ  
CFR Regulation Number888.3360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-12-07
Decision Date2000-05-04
Summary:summary

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