FDA.report

510(k) K962002

Device
AURA HIP SYSTEM CALCAR REPLACEMENT FEMORAL STEM
Applicant
EXACTECH, INC.
510(k) number
K962002
Product code
JDG  
Decision
Substantially Equivalent (SESE)
Decision date
1996-08-08
Date received
1996-05-22
Regulation
888.3360
Classification name
Prosthesis, Hip, Femoral Component, Cemented, Metal
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
MARTHA C MILLER
Address
4613 NW 6th St., Suite D Gainesville FL US 32609 32609

FDA Registration Numbers

Source Documents

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

Related GUDID Devices

Primary DIBrandCompanyPublished
10885862014870AuRaExactech, Inc.2015-10-30
10885862014863AuRaExactech, Inc.2015-10-30
10885862014856AuRaExactech, Inc.2015-10-30
10885862014849AuRaExactech, Inc.2015-10-30
10885862014832AuRaExactech, Inc.2015-10-30
10885862014825AuRaExactech, Inc.2015-10-30

Legacy Summary

summary

FDA Review

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