Product code JDX
- Device name
- Instrument, Surgical, Sonic And Accessory/Attachment
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.4580
- Review panel
- OR
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K201274 | Ultrasonic Osteotomy Surgical System | Smtp Technology Co., Ltd. | 2021-02-19 |
| K172464 | XD880A Ultrasonic Osteotomy Surgical System | Morley Research Consortium | 2018-04-24 |
| K163610 | PIEZOTOME M+, PIEZOTOME M+ Handpiece | Satalec-Acteon Group | 2017-05-19 |
| K153743 | PIEZOSURGERY PLUS | Mectron S.P.A. | 2016-05-25 |
| K132848 | PIEZOSURGERY FLEX | Mectron S.P.A. | 2013-11-29 |
| K100410 | PIEZOELECTRIC SYSTEM | Satelec | 2010-04-28 |
| K093805 | OSCAR 3 | Orthosonics, Ltd. | 2010-02-19 |
| K083284 | PIEZOSURGERY MEDICAL | Piezosurgery S.R.L. | 2009-04-08 |
| K083830 | OSCAR BONE RESECTOR | Orthosonics, Ltd. | 2009-03-20 |
| K072961 | LOTUS ULTRASONIC SYSTEM FOR CEMENTED IMPLANT EXTRACTION (USCIX) | Sra Developments, Ltd. | 2007-12-19 |
| K051053 | OSCAR, MODEL OE3000DB | Orthosonics, Ltd. | 2005-07-21 |
| K031280 | ULTRA-DRIVE 3 | Biomet, Inc. | 2003-09-22 |
| K022729 | VENTED CEMENT RESTRICTOR | Amedica Corp. | 2002-11-14 |
| K002484 | EMS SWISS ORTHOCLAST CHISELS FOR NON-CEMENTED PROSTHESIS REMOVAL | Electro Medical Systems SA | 2000-10-04 |
| K961725 | OSCAR ORTHOSONICS SYSTEM FOR CEMENTED ARTHROPLASTY REVISION | C.L. Mcintosh & Assoc., Inc. | 1996-08-01 |
| K930109 | KOMET MEDICAL SURGICAL POWER ACCESORIES | Brassler USA | 1993-08-25 |
| K912931 | ITM SONIC SURGERY SYSTEM | Buckman Co., Inc. | 1991-10-03 |
| K911548 | ACRYL-X SYSTEM TM | Sonokinetics, Inc. | 1991-06-28 |
| K905451 | SYSTEM TEN, MODEL 100 SURGERY SYST/ORTHOPAEDIC USE | Advanced Osseous Technologies | 1991-03-05 |
| K900003 | SYSTEM TEN MODEL 100 SURGICAL SYSTEM | Advanced Osseous Technologies | 1990-03-16 |
| K891408 | MODIFIED PROFILE HIP ACETABULAR PROSTHESIS | Depuy, Inc. | 1989-06-12 |
| K862504 | ACE MOS SAW AND THE ACE MOS SPINE SAW | Buckman Co., Inc. | 1986-08-07 |
| K800501 | PFIZER/AS&E 0450 LOCALIZER | Pfizer Medical Systems, Inc. | 1980-04-10 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| J021305030021 | Piezomed Pro Accessory | W & H Dentalwerk Bürmoos GmbH | 2025-09-22 |
| J021305030011 | Piezomed Pro Accessory | W & H Dentalwerk Bürmoos GmbH | 2025-09-22 |
| J021305030001 | Piezomed Pro Accessory | W & H Dentalwerk Bürmoos GmbH | 2025-09-22 |
| J021305020131 | Piezomed Pro Accessory | W & H Dentalwerk Bürmoos GmbH | 2025-07-08 |
| J021305020241 | Piezomed Pro Accessory | W & H Dentalwerk Bürmoos GmbH | 2025-07-08 |
| J021305020231 | Piezomed Pro Accessory | W & H Dentalwerk Bürmoos GmbH | 2025-07-08 |
| J021305020221 | Piezomed Pro Accessory | W & H Dentalwerk Bürmoos GmbH | 2025-07-08 |
| J021305020211 | Piezomed Pro Accessory | W & H Dentalwerk Bürmoos GmbH | 2025-07-08 |
| J021305020201 | Piezomed Pro Accessory | W & H Dentalwerk Bürmoos GmbH | 2025-07-08 |
| J021305020191 | Piezomed Pro Accessory | W & H Dentalwerk Bürmoos GmbH | 2025-07-08 |
| J021305020181 | Piezomed Pro Accessory | W & H Dentalwerk Bürmoos GmbH | 2025-07-08 |
| J021305020171 | Piezomed Pro Accessory | W & H Dentalwerk Bürmoos GmbH | 2025-07-08 |
| J021305020161 | Piezomed Pro Accessory | W & H Dentalwerk Bürmoos GmbH | 2025-07-08 |
| J021305020151 | Piezomed Pro Accessory | W & H Dentalwerk Bürmoos GmbH | 2025-07-08 |
| J021305020141 | Piezomed Pro Accessory | W & H Dentalwerk Bürmoos GmbH | 2025-07-08 |
| J021305000001 | Piezomed Pro M-PM100 | W & H Dentalwerk Bürmoos GmbH | 2025-07-08 |
| J021305020121 | Piezomed Pro Accessory | W & H Dentalwerk Bürmoos GmbH | 2025-07-08 |
| J021305020111 | Piezomed Pro Accessory | W & H Dentalwerk Bürmoos GmbH | 2025-07-08 |
| J021305020101 | Piezomed Pro Accessory | W & H Dentalwerk Bürmoos GmbH | 2025-07-08 |
| J021305020091 | Piezomed Pro Accessory | W & H Dentalwerk Bürmoos GmbH | 2025-07-08 |
| J021305020081 | Piezomed Pro Accessory | W & H Dentalwerk Bürmoos GmbH | 2025-07-08 |
| J021305020071 | Piezomed Pro Accessory | W & H Dentalwerk Bürmoos GmbH | 2025-07-08 |
| J021305020061 | Piezomed Pro Accessory | W & H Dentalwerk Bürmoos GmbH | 2025-07-08 |
| J021305020051 | Piezomed Pro Accessory | W & H Dentalwerk Bürmoos GmbH | 2025-07-08 |
| J021305020041 | Piezomed Pro Accessory | W & H Dentalwerk Bürmoos GmbH | 2025-07-08 |
| J021305020031 | Piezomed Pro Accessory | W & H Dentalwerk Bürmoos GmbH | 2025-07-08 |
| J021305020021 | Piezomed Pro Accessory | W & H Dentalwerk Bürmoos GmbH | 2025-07-08 |
| J021305020011 | Piezomed Pro Accessory | W & H Dentalwerk Bürmoos GmbH | 2025-07-08 |
| J021305020001 | Piezomed Pro Accessory | W & H Dentalwerk Bürmoos GmbH | 2025-07-08 |
| J021305010001 | Piezomed Pro M-PH350 | W & H Dentalwerk Bürmoos GmbH | 2025-07-08 |