OSTEONICS SOLAR SHOULDER HUMERAL BEARING HEAD

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

HOWMEDICA OSTEONICS CORP.

The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Osteonics Solar Shoulder Humeral Bearing Head.

Pre-market Notification Details

Device IDK990598
510k NumberK990598
Device Name:OSTEONICS SOLAR SHOULDER HUMERAL BEARING HEAD
ClassificationProsthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
Applicant HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale,  NJ  07401 -1677
ContactMarybeth Naughton
CorrespondentMarybeth Naughton
HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale,  NJ  07401 -1677
Product CodeKWS  
CFR Regulation Number888.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-02-24
Decision Date1999-03-15
Summary:summary

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