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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 K945426
Device Name ARTHREX CANCELLOUS SCREW AND WASHER
Applicant
Arthrex, Inc.
3050 N. Horseshoe Dr.
Suite 200
Naples,  FL  33942
Applicant Contact LEONARD E BALTZ, JR.
Correspondent
Arthrex, Inc.
3050 N. Horseshoe Dr.
Suite 200
Naples,  FL  33942
Correspondent Contact LEONARD E BALTZ, JR.
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
HTN  
Date Received11/04/1994
Decision Date 04/14/1995
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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