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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 K052241
Device Name DISC-FX SYSTEM
Applicant
Ellman International, Inc.
3333 Royal Ave.
Oceanside,  NY  11572
Applicant Contact JOAN CARTER
Correspondent
Ellman International, Inc.
3333 Royal Ave.
Oceanside,  NY  11572
Correspondent Contact JOAN CARTER
Regulation Number888.1100
Classification Product Code
HRX  
Subsequent Product Code
GEI  
Date Received08/17/2005
Decision Date 02/24/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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