METAL TRANSCEND ARTICULATION SYSTEM

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

WRIGHT MEDICAL TECHNOLOGY, INC.

The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Metal Transcend Articulation System.

Pre-market Notification Details

Device IDK004043
510k NumberK004043
Device Name:METAL TRANSCEND ARTICULATION SYSTEM
ClassificationProsthesis, Hip, Semi-constrained (metal Cemented Acetabular Component)
Applicant WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington,  TN  38002
ContactEhab M Esmail
CorrespondentEhab M Esmail
WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington,  TN  38002
Product CodeJDL  
CFR Regulation Number888.3320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-12-29
Decision Date2001-07-13
Summary:summary

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