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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurological Stereotaxic Instrument
510(k) Number K033011
Device Name ZIMMER ORTHO GUIDANCE SYSTEMS- KNEE INSTRUMENTS
Applicant
ZIMMER, INC.
P.O. BOX 708
WARSAW,  IN  46581 -0708
Applicant Contact STEPHEN H MCKELVEY
Correspondent
ZIMMER, INC.
P.O. BOX 708
WARSAW,  IN  46581 -0708
Correspondent Contact STEPHEN H MCKELVEY
Regulation Number882.4560
Classification Product Code
HAW  
Date Received09/26/2003
Decision Date 02/12/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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