SELECT SHOULDER OFFSET HUMERAL HEAD COMPONENTS

Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented

SULZER ORTHOPEDICS, INC.

The following data is part of a premarket notification filed by Sulzer Orthopedics, Inc. with the FDA for Select Shoulder Offset Humeral Head Components.

Pre-market Notification Details

Device IDK971715
510k NumberK971715
Device Name:SELECT SHOULDER OFFSET HUMERAL HEAD COMPONENTS
ClassificationProsthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
Applicant SULZER ORTHOPEDICS, INC. 9900 SPECTRUM DR. Austin,  TX  78717
ContactJacquelyn Hughes
CorrespondentJacquelyn Hughes
SULZER ORTHOPEDICS, INC. 9900 SPECTRUM DR. Austin,  TX  78717
Product CodeKWS  
Subsequent Product CodeHSD
Subsequent Product CodeKWT
CFR Regulation Number888.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-05-09
Decision Date1997-08-07
Summary:summary

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