FDA.report

510(k) K040128

Device
MODIFICATION TO MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEMS
Applicant
HOWMEDICA OSTEONICS CORP
510(k) number
K040128
Product code
HSD  
Decision
Substantially Equivalent (SESE)
Decision date
2004-03-26
Date received
2004-01-21
Regulation
888.3690
Classification name
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
MARGARET F CROWE
Address
325 Corporate Dr. Mahwah NJ US 07430 07430

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Legacy Summary

summary

FDA Review

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