SORIBIE RESURFACING TOTAL ELBOW SYSTEM (PROPOSED NAME)

Prosthesis, Elbow, Semi-constrained, Cemented

WRIGHT MEDICAL TECHNOLOGY, INC.

The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Soribie Resurfacing Total Elbow System (proposed Name).

Pre-market Notification Details

Device IDK960087
510k NumberK960087
Device Name:SORIBIE RESURFACING TOTAL ELBOW SYSTEM (PROPOSED NAME)
ClassificationProsthesis, Elbow, Semi-constrained, Cemented
Applicant WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington,  TN  38002
ContactJudy English
CorrespondentJudy English
WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington,  TN  38002
Product CodeJDB  
CFR Regulation Number888.3160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-01-11
Decision Date1996-09-20
Summary:summary

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