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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Mill
510(k) Number K860356
Device Name ORTHOBLEND POWERED BONE MILL
Applicant
Zimmer, Inc.
P.O. Box 708
Warsaw,  IN  46581
Applicant Contact HENRY A QUELLO
Correspondent
Zimmer, Inc.
P.O. Box 708
Warsaw,  IN  46581
Correspondent Contact HENRY A QUELLO
Regulation Number888.4540
Classification Product Code
LYS  
Date Received01/30/1986
Decision Date 07/08/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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