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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Surgical, Sonic And Accessory/Attachment
510(k) Number K072961
Device Name LOTUS ULTRASONIC SYSTEM FOR CEMENTED IMPLANT EXTRACTION (USCIX)
Applicant
Sra Developments, Ltd.
Bremridge House
Ashburton, Devon,  GB TQ13 7JX
Applicant Contact MICHAEL J.R. YOUNG
Correspondent
Sra Developments, Ltd.
Bremridge House
Ashburton, Devon,  GB TQ13 7JX
Correspondent Contact MICHAEL J.R. YOUNG
Regulation Number888.4580
Classification Product Code
JDX  
Date Received10/19/2007
Decision Date 12/19/2007
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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