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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Staple, Fixation, Bone
510(k) Number K943492
Device Name ARTHREX STAPLES
Applicant
Arthrex, Inc.
3050 N. Horseshoe Dr.
Suite 200
Naples,  FL  33942
Applicant Contact LEONARD E BALTZ
Correspondent
Arthrex, Inc.
3050 N. Horseshoe Dr.
Suite 200
Naples,  FL  33942
Correspondent Contact LEONARD E BALTZ
Regulation Number888.3030
Classification Product Code
JDR  
Subsequent Product Code
HXJ  
Date Received07/19/1994
Decision Date 02/01/1995
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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