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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 K132848
FOIA Releasable 510(k) K132848
Device Name PIEZOSURGERY FLEX
Applicant
Mectron S.P.A.
Piazza Albania 10
Rome,  IT 00153
Applicant Contact ROGER GRAY
Correspondent
Mectron S.P.A.
Piazza Albania 10
Rome,  IT 00153
Correspondent Contact ROGER GRAY
Regulation Number888.4580
Classification Product Code
JDX  
Subsequent Product Codes
DZI   ERL   HBE   HWE  
Date Received09/11/2013
Decision Date 11/29/2013
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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