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510(k) K960363

Device
BIPOLAR SHOULDER PROSTHESIS-SHELL(RD-113130/33, BIANGULAR MODULAR HEAD(RD-113101/41/42,BIOMODULAR MODULAR HEAD(RD-113143
Applicant
BIOMET, INC.
510(k) number
K960363
Product code
MJT  
Decision
Substantially Equivalent (SESE)
Decision date
1997-02-18
Date received
1996-01-25
Regulation
510(k) Premarket Notification
Classification name
Prosthesis, Shoulder, Humeral (bipolar Hemi-shoulder) Metal/polymer, Cemented Or Uncemented
Medical specialty
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
Review panel
Orthopedic
Device class
3
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
PATRICIA S BERES
Address
Airport Industrial Park Warsaw IN US 46581 46581

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MJT  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K990712OSTEONICS SOLAR SHOULDER BIPOLAR SYSTEMHowmedica Osteonics Corp.1999-07-20
K982418BUECHEL-PAPPAS MODULAR SALVAGE STEMEndotec, Inc.1999-04-29

Legacy Summary#

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FDA Review#

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