Panels › Orthopedic › Product code JDX · Class 2
Instrument, Surgical, Sonic And Accessory/Attachment
Regulation 888.4580
0510(k)s in 12 months (23 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in JDX
| Company | 510(k)s | Recalls |
|---|---|---|
| Orthosonics, Ltd. | 3 | 0 |
| Advanced Osseous Technologies | 2 | 0 |
| Buckman Co., Inc. | 2 | 0 |
| Mectron S.P.A. | 2 | 0 |
| Zimmer Biomet, Inc. | 0 | 2 |
| Amedica Corp. | 1 | 0 |
| Biomet, Inc. | 1 | 0 |
| Brassler USA | 1 | 0 |
| C.L. Mcintosh & Assoc., Inc. | 1 | 0 |
| Depuy, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 19, 2021 | K201274 | Ultrasonic Osteotomy Surgical System Smtp Technology Co., Ltd., CN | JDX |
| Apr 24, 2018 | K172464 | XD880A Ultrasonic Osteotomy Surgical System Morley Research Consortium | JDX |
| May 19, 2017 | K163610 | PIEZOTOME M+, PIEZOTOME M+ Handpiece Satalec-Acteon Group, FR | JDX |
| May 25, 2016 | K153743 | PIEZOSURGERY PLUS Mectron S.P.A., IT | JDX |
| Nov 29, 2013 | K132848 | PIEZOSURGERY FLEX Mectron S.P.A., IT | JDX |
| Apr 28, 2010 | K100410 | PIEZOELECTRIC SYSTEM Satelec | JDX |
| Feb 19, 2010 | K093805 | OSCAR 3 Orthosonics, Ltd., GB | JDX |
| Apr 8, 2009 | K083284 | PIEZOSURGERY MEDICAL Piezosurgery S.R.L., IT | JDX |
| Mar 20, 2009 | K083830 | OSCAR BONE RESECTOR Orthosonics, Ltd., GB | JDX |
| Dec 19, 2007 | K072961 | LOTUS ULTRASONIC SYSTEM FOR CEMENTED IMPLANT EXTRACTION (USCIX) Sra Developments, Ltd., GB | JDX |
| Jul 21, 2005 | K051053 | OSCAR, MODEL OE3000DB Orthosonics, Ltd. | JDX |
| Sep 22, 2003 | K031280 | ULTRA-DRIVE 3 Biomet, Inc. | JDX |
| Nov 14, 2002 | K022729 | VENTED CEMENT RESTRICTOR Amedica Corp. | JDX |
| Oct 4, 2000 | K002484 | EMS SWISS ORTHOCLAST CHISELS FOR NON-CEMENTED PROSTHESIS REMOVAL Electro Medical Systems SA | JDX |
| Aug 1, 1996 | K961725 | OSCAR ORTHOSONICS SYSTEM FOR CEMENTED ARTHROPLASTY REVISION C.L. Mcintosh & Assoc., Inc. | JDX |
| Aug 25, 1993 | K930109 | KOMET MEDICAL SURGICAL POWER ACCESORIES Brassler USA | JDX |
| Oct 3, 1991 | K912931 | ITM SONIC SURGERY SYSTEM Buckman Co., Inc. | JDX |
| Jun 28, 1991 | K911548 | ACRYL-X SYSTEM TM Sonokinetics, Inc. | JDX |
| Mar 5, 1991 | K905451 | SYSTEM TEN, MODEL 100 SURGERY SYST/ORTHOPAEDIC USE Advanced Osseous Technologies | JDX |
| Mar 16, 1990 | K900003 | SYSTEM TEN MODEL 100 SURGICAL SYSTEM Advanced Osseous Technologies | JDX |
| Jun 12, 1989 | K891408 | MODIFIED PROFILE HIP ACETABULAR PROSTHESIS Depuy, Inc. | JDX |
| Aug 7, 1986 | K862504 | ACE MOS SAW AND THE ACE MOS SPINE SAW Buckman Co., Inc. | JDX |
| Apr 10, 1980 | K800501 | PFIZER/AS&E 0450 LOCALIZER Pfizer Medical Systems, Inc. | JDX |
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