REUNION HA FRACTURE STEM

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

HOWMEDICA OSTEONICS CORP

The following data is part of a premarket notification filed by Howmedica Osteonics Corp with the FDA for Reunion Ha Fracture Stem.

Pre-market Notification Details

Device IDK070963
510k NumberK070963
Device Name:REUNION HA FRACTURE STEM
ClassificationProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Applicant HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah,  NJ  07430
ContactFrancisco Haro
CorrespondentFrancisco Haro
HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah,  NJ  07430
Product CodeHSD  
CFR Regulation Number888.3690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-04-05
Decision Date2007-05-04
Summary:summary

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