FDA.report

510(k) K823727

Device
SPECTRON PRIMARY STEM FEMORAL PROSTHES
Applicant
RICHARD'S MEDICAL EQUIP., INC.
510(k) number
K823727
Product code
JDI  
Decision
Substantially Equivalent (SESE)
Decision date
1983-03-08
Date received
1982-12-10
Regulation
888.3350
Classification name
Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON

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Legacy Summary

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FDA Review

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