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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arthroscope
510(k) Number K072879
Device Name INNERVUE DIAGNOSTIC SCOPE SYSTEM
Applicant
BIOMET ORTHOPEDICS, INC.
56 EAST BELL DR.
P.O. BOX 587
WARSAW,  IN  46581 -0587
Applicant Contact SUSAN ALEXANDER
Correspondent
BIOMET ORTHOPEDICS, INC.
56 EAST BELL DR.
P.O. BOX 587
WARSAW,  IN  46581 -0587
Correspondent Contact SUSAN ALEXANDER
Regulation Number888.1100
Classification Product Code
HRX  
Date Received10/09/2007
Decision Date 01/14/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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