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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K120527
Device Name ALPHA ORTHOPAEDICS AT2 SYSTEM
Applicant
Alpha Orthopaedics, Inc.
7700 Adgewater Dr.
Suite # 405
Oakland,  CA  94621
Applicant Contact GINA TO
Correspondent
Alpha Orthopaedics, Inc.
7700 Adgewater Dr.
Suite # 405
Oakland,  CA  94621
Correspondent Contact GINA TO
Regulation Number878.4400
Classification Product Code
GEI  
Date Received02/22/2012
Decision Date 06/18/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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