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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
510(k) Number K963709
Device Name CEMENT-ON FEMORAL STEM
Applicant
BIOMET, INC.
AIRPORT INDUSTRIAL PARK
WARSAW,  IN  46581
Applicant Contact KARA L SCHWARTZ
Correspondent
BIOMET, INC.
AIRPORT INDUSTRIAL PARK
WARSAW,  IN  46581
Correspondent Contact KARA L SCHWARTZ
Regulation Number888.3560
Classification Product Code
JWH  
Date Received09/16/1996
Decision Date 12/04/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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