HOWMEDICCA MODULAR PROXIMAL HUMERUS REPLACEMENT SYSTEM

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

HOWMEDICA CORP.

The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Howmedicca Modular Proximal Humerus Replacement System.

Pre-market Notification Details

Device IDK954559
510k NumberK954559
Device Name:HOWMEDICCA MODULAR PROXIMAL HUMERUS REPLACEMENT SYSTEM
ClassificationProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Applicant HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford,  NJ  07070
ContactMargaret F Crowe
CorrespondentMargaret F Crowe
HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford,  NJ  07070
Product CodeHSD  
CFR Regulation Number888.3690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-10-02
Decision Date1996-07-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07613327049060 K954559 000
07613327048681 K954559 000
07613327048940 K954559 000
07613327048957 K954559 000
07613327048964 K954559 000
07613327048971 K954559 000
07613327048988 K954559 000
07613327048995 K954559 000
07613327049008 K954559 000
07613327049015 K954559 000
07613327049022 K954559 000
07613327049039 K954559 000
07613327049046 K954559 000
07613327048667 K954559 000

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