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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K923256
Device Name ALPHATEC 2.7 MM CANNULATED CORTICAL LAG SCREW
Applicant
Alphatec Mfg., Inc.
42-160 State St.
Palm Desert,  CA  92211
Applicant Contact THOMAS A HOGHAUG
Correspondent
Alphatec Mfg., Inc.
42-160 State St.
Palm Desert,  CA  92211
Correspondent Contact THOMAS A HOGHAUG
Regulation Number888.3040
Classification Product Code
HWC  
Date Received07/02/1992
Decision Date 10/09/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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