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JDX — Instrument, Surgical, Sonic And Accessory/Attachment Class II

FDA Device Classification

Classification Details

Product Code
JDX
Device Class
Class II
Regulation Number
888.4580
Submission Type
Review Panel
OR
Medical Specialty
Orthopedic
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K201274smtp technology coUltrasonic Osteotomy Surgical SystemFebruary 19, 2021
K172464morley research consortiumXD880A Ultrasonic Osteotomy Surgical SystemApril 24, 2018
K163610satalec-acteon groupPIEZOTOME M+, PIEZOTOME M+ HandpieceMay 19, 2017
K153743mectronPIEZOSURGERY PLUSMay 25, 2016
K132848mectronPIEZOSURGERY FLEXNovember 29, 2013
K100410satelecPIEZOELECTRIC SYSTEMApril 28, 2010
K093805orthosonicsOSCAR 3February 19, 2010
K083284piezosurgeryPIEZOSURGERY MEDICALApril 8, 2009
K083830orthosonicsOSCAR BONE RESECTORMarch 20, 2009
K072961sra developmentsLOTUS ULTRASONIC SYSTEM FOR CEMENTED IMPLANT EXTRACTION (USCIX)December 19, 2007
K051053orthosonicsOSCAR, MODEL OE3000DBJuly 21, 2005
K031280biometULTRA-DRIVE 3September 22, 2003
K022729amedicaVENTED CEMENT RESTRICTORNovember 14, 2002
K002484electro medical systemsEMS SWISS ORTHOCLAST CHISELS FOR NON-CEMENTED PROSTHESIS REMOVALOctober 4, 2000
K961725c.l. mcintosh and assocOSCAR ORTHOSONICS SYSTEM FOR CEMENTED ARTHROPLASTY REVISIONAugust 1, 1996
K930109brassler usaKOMET MEDICAL SURGICAL POWER ACCESORIESAugust 25, 1993
K912931buckman coITM SONIC SURGERY SYSTEMOctober 3, 1991
K911548sonokineticsACRYL-X SYSTEM TMJune 28, 1991
K905451advanced osseous technologiesSYSTEM TEN, MODEL 100 SURGERY SYST/ORTHOPAEDIC USEMarch 5, 1991
K900003advanced osseous technologiesSYSTEM TEN MODEL 100 SURGICAL SYSTEMMarch 16, 1990