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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Motor, Surgical Instrument, Ac-Powered
510(k) Number K050519
Device Name ADVANCED TURBO DRIVE SYSTEM
Applicant
Linvatec Corp.
11311 Concept Blvd.
Largo,  FL  33773
Applicant Contact ELIZABETH PAUL
Correspondent
Linvatec Corp.
11311 Concept Blvd.
Largo,  FL  33773
Correspondent Contact ELIZABETH PAUL
Regulation Number878.4820
Classification Product Code
GEY  
Date Received03/01/2005
Decision Date 05/17/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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