JDX · Class II · 21 CFR 888.4580

FDA Product Code JDX: Instrument, Surgical, Sonic And Accessory/attachment

Leading manufacturers include Buckman Co., Inc., Orthosonics, Ltd. and Mectron S.P.A..

23
Total
23
Cleared
111d
Avg days
1980
Since

FDA 510(k) Cleared Instrument, Surgical, Sonic And Accessory/attachment Devices (Product Code JDX)

23 devices
1–23 of 23
Cleared Feb 19, 2021
Ultrasonic Osteotomy Surgical System
K201274
Smtp Technology Co., Ltd.
Orthopedic · 283d
Cleared Apr 24, 2018
XD880A Ultrasonic Osteotomy Surgical System
K172464
Morley Research Consortium
Orthopedic · 253d
Cleared May 19, 2017
PIEZOTOME M+, PIEZOTOME M+ Handpiece
K163610
Satalec-Acteon Group
Orthopedic · 148d
Cleared May 25, 2016
PIEZOSURGERY PLUS
K153743
Mectron S.P.A.
Orthopedic · 149d
Cleared Nov 29, 2013
PIEZOSURGERY FLEX
K132848
Mectron S.P.A.
Orthopedic · 79d
Cleared Apr 28, 2010
PIEZOELECTRIC SYSTEM
K100410
Satelec
Orthopedic · 71d
Cleared Apr 08, 2009
PIEZOSURGERY MEDICAL
K083284
Piezosurgery S.R.L.
Orthopedic · 152d
Cleared Mar 20, 2009
OSCAR BONE RESECTOR
K083830
Orthosonics, Ltd.
Orthopedic · 87d
Cleared Dec 19, 2007
LOTUS ULTRASONIC SYSTEM FOR CEMENTED IMPLANT EXTRACTION (USCIX)
K072961
Sra Developments, Ltd.
Orthopedic · 61d
Cleared Jul 21, 2005
OSCAR, MODEL OE3000DB
K051053
Orthosonics, Ltd.
Orthopedic · 87d
Cleared Sep 22, 2003
ULTRA-DRIVE 3
K031280
Biomet, Inc.
Neurology · 153d
Cleared Nov 14, 2002
VENTED CEMENT RESTRICTOR
K022729
Amedica Corp.
Orthopedic · 90d
Cleared Aug 01, 1996
OSCAR ORTHOSONICS SYSTEM FOR CEMENTED ARTHROPLASTY REVISION
K961725
C.L. Mcintosh & Assoc., Inc.
Orthopedic · 90d
Cleared Oct 03, 1991
ITM SONIC SURGERY SYSTEM
K912931
Buckman Co., Inc.
Orthopedic · 90d
Cleared Jun 12, 1989
MODIFIED PROFILE HIP ACETABULAR PROSTHESIS
K891408
Depuy, Inc.
Orthopedic · 90d
Cleared Aug 07, 1986
ACE MOS SAW AND THE ACE MOS SPINE SAW
K862504
Buckman Co., Inc.
Orthopedic · 37d

About Product Code JDX - Regulatory Context