MODULAR REPLACEMENT ELBOW SYSTEM

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 Modular Replacement Elbow System.

Pre-market Notification Details

Device IDK062845
510k NumberK062845
Device Name:MODULAR REPLACEMENT ELBOW SYSTEM
ClassificationProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Applicant HOWMEDICA OSTEONICS CORP. 325 Corporate Drive Mahwah,  NJ  07430
ContactFrancisco Haro
CorrespondentFrancisco Haro
HOWMEDICA OSTEONICS CORP. 325 Corporate Drive Mahwah,  NJ  07430
Product CodeHSD  
CFR Regulation Number888.3690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-09-22
Decision Date2006-12-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07613327139303 K062845 000
07613327138412 K062845 000
07613327138450 K062845 000
07613327138467 K062845 000
07613327138474 K062845 000
07613327138481 K062845 000
07613327138498 K062845 000
07613327139167 K062845 000
07613327139181 K062845 000
07613327139198 K062845 000
07613327139204 K062845 000
07613327139211 K062845 000
07613327139266 K062845 000
07613327138221 K062845 000

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