FDA.report

510(k) K936127

Device
HOWMEDICA PREMIUM FEMORAL COMPONENT
Applicant
HOWMEDICA, INC.
510(k) number
K936127
Product code
JDI  
Decision
Substantially Equivalent (SESE)
Decision date
1994-10-26
Date received
1993-12-23
Regulation
888.3350
Classification name
Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
ROBERT E SMITH
Address
359 Veterans Blvd. Rutherford NJ US 07070 07070

FDA Registration Numbers

Source Documents

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

Legacy Summary

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FDA Review

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