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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 K931538
Device Name AMSET(TM) CANNULATED BONE SCREW
Applicant
Advanced Med/Surg, Inc.
25590 Seaboard Ln.
Hayward,  CA  94545
Applicant Contact RONALD C ALLEN
Correspondent
Advanced Med/Surg, Inc.
25590 Seaboard Ln.
Hayward,  CA  94545
Correspondent Contact RONALD C ALLEN
Regulation Number888.3040
Classification Product Code
HWC  
Date Received03/29/1993
Decision Date 05/04/1994
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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