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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Needle
510(k) Number K110419
Device Name AVS ARIA NEUROMONITORING PROBE AND AVS ARIA PROBE DILATORS
Applicant
Stryker Spine
2 Pearl Ct.
Allendale,  NJ  07401
Applicant Contact TIFFANI D ROGERS
Correspondent
Stryker Spine
2 Pearl Ct.
Allendale,  NJ  07401
Correspondent Contact TIFFANI D ROGERS
Regulation Number882.1350
Classification Product Code
GXZ  
Date Received02/14/2011
Decision Date 07/28/2011
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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