FDA 510(k) Applications for Medical Device Product Code "JDX"
(Instrument, Surgical, Sonic And Accessory/Attachment)

FDA 510(k) Number Applicant Device Name Decision Date
K022729 AMEDICA CORP. VENTED CEMENT RESTRICTOR 11/14/2002
K031280 BIOMET, INC. ULTRA-DRIVE 3 09/22/2003
K961725 C.L. MCINTOSH & ASSOC., INC. OSCAR ORTHOSONICS SYSTEM FOR CEMENTED ARTHROPLASTY REVISION 08/01/1996
K002484 ELECTRO MEDICAL SYSTEMS SA EMS SWISS ORTHOCLAST CHISELS FOR NON-CEMENTED PROSTHESIS REMOVAL 10/04/2000
K132848 MECTRON S.P.A. PIEZOSURGERY FLEX 11/29/2013
K153743 MECTRON SPA PIEZOSURGERY PLUS 05/25/2016
K172464 Morley Research Consortium XD880A Ultrasonic Osteotomy Surgical System 04/24/2018
K093805 ORTHOSONICS, LTD. OSCAR 3 02/19/2010
K083830 ORTHOSONICS, LTD. OSCAR BONE RESECTOR 03/20/2009
K051053 ORTHOSONICS, LTD. OSCAR, MODEL OE3000DB 07/21/2005
K083284 PIEZOSURGERY SRL PIEZOSURGERY MEDICAL 04/08/2009
K163610 SATALEC-ACTEON GROUP PIEZOTOME M+, PIEZOTOME M+ Handpiece 05/19/2017
K100410 SATELEC PIEZOELECTRIC SYSTEM 04/28/2010
K201274 SMTP Technology Co., Ltd Ultrasonic Osteotomy Surgical System 02/19/2021
K072961 SRA DEVELOPMENTS, LTD. LOTUS ULTRASONIC SYSTEM FOR CEMENTED IMPLANT EXTRACTION (USCIX) 12/19/2007


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