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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, femorotibial, constrained, cemented, metal/polymer
510(k) Number K083827
Device Name ORTHOPEDIC SALVAGE SYSTEM (OSS) 9CM COBALT - CHROME TIBIAL BODIES
Applicant
BIOMET MANUFACTURING CORP.
PO BOX 587
WARSAW,  IN  46581 -0587
Applicant Contact GARY BAKER
Correspondent
BIOMET MANUFACTURING CORP.
PO BOX 587
WARSAW,  IN  46581 -0587
Correspondent Contact GARY BAKER
Regulation Number888.3510
Classification Product Code
KRO  
Date Received12/23/2008
Decision Date 02/13/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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