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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, non-constrained, cemented, metal/polymer
510(k) Number K862632
Device Name INSALL/BURSTEIN(TM)* II TIBIAL WEDGES
Applicant
ZIMMER, INC.
P.O. BOX 708
WARSAW,  IN  46581 -0708
Applicant Contact MAX SHERMAN
Correspondent
ZIMMER, INC.
P.O. BOX 708
WARSAW,  IN  46581 -0708
Correspondent Contact MAX SHERMAN
Regulation Number888.3520
Classification Product Code
HSX  
Date Received07/10/1986
Decision Date 03/25/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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