HA MCCUTCHEN SLT HIP SYSTEM

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

DOW CORNING WRIGHT

The following data is part of a premarket notification filed by Dow Corning Wright with the FDA for Ha Mccutchen Slt Hip System.

Pre-market Notification Details

Device IDK912452
510k NumberK912452
Device Name:HA MCCUTCHEN SLT HIP SYSTEM
ClassificationProsthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
Applicant DOW CORNING WRIGHT P.O. BOX 100 Arlington,  TN  38002
ContactMicki Roy
CorrespondentMicki Roy
DOW CORNING WRIGHT P.O. BOX 100 Arlington,  TN  38002
Product CodeMEH  
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-06-03
Decision Date1991-10-04

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