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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 K140868
Device Name STRYKER KWIC NEEDLE
Applicant
Orthovita, Inc.
77 Great Valley Pkwy.
Malvern,  PA  19355
Applicant Contact John Urtz
Correspondent
Orthovita, Inc.
77 Great Valley Pkwy.
Malvern,  PA  19355
Correspondent Contact John Urtz
Regulation Number882.4560
Classification Product Code
HAW  
Subsequent Product Code
KNW  
Date Received04/03/2014
Decision Date 06/05/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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