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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arthroscope
510(k) Number K922890
Device Name ARTHREX KNEE ARTHROSCOPIC SURGERY ACCESSORIES
Applicant
Arthrex, Inc.
3050 N. Horseshoe Dr.
Suite 200
Naples,  FL  33942
Applicant Contact BALTZ, JR
Correspondent
Arthrex, Inc.
3050 N. Horseshoe Dr.
Suite 200
Naples,  FL  33942
Correspondent Contact BALTZ, JR
Regulation Number888.1100
Classification Product Code
HRX  
Date Received06/15/1992
Decision Date 02/08/1993
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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