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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
510(k) Number K993873
Device Name ALPHATEC EXTERNAL FIXATION SYSTEM COMPRESSION/DISTRACTION ROD
Applicant
Alphatec Mfg., Inc.
42-160 State St.
Palm Desert,  CA  92211
Applicant Contact JASON BLAIN
Correspondent
Alphatec Mfg., Inc.
42-160 State St.
Palm Desert,  CA  92211
Correspondent Contact JASON BLAIN
Regulation Number888.3030
Classification Product Code
KTT  
Date Received11/15/1999
Decision Date 01/03/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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