FDA Product Code
FDA Product Code JDX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.4580
510(k) Clearances — 23 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K201274 | Ultrasonic Osteotomy Surgical System | Smtp Technology Co., Ltd. | 2021-02-19 | Traditional | PDF ↗ |
| K172464 | XD880A Ultrasonic Osteotomy Surgical System | Morley Research Consortium | 2018-04-24 | Traditional | PDF ↗ |
| K163610 | PIEZOTOME M+, PIEZOTOME M+ Handpiece | Satalec-Acteon Group | 2017-05-19 | Traditional | PDF ↗ |
| K153743 | PIEZOSURGERY PLUS | Mectron S.P.A. | 2016-05-25 | Traditional | PDF ↗ |
| K132848 | PIEZOSURGERY FLEX | Mectron S.P.A. | 2013-11-29 | Traditional | PDF ↗ |
| K100410 | PIEZOELECTRIC SYSTEM | Satelec | 2010-04-28 | Traditional | PDF ↗ |
| K093805 | OSCAR 3 | Orthosonics, Ltd. | 2010-02-19 | Traditional | PDF ↗ |
| K083284 | PIEZOSURGERY MEDICAL | Piezosurgery S.R.L. | 2009-04-08 | Traditional | PDF ↗ |
| K083830 | OSCAR BONE RESECTOR | Orthosonics, Ltd. | 2009-03-20 | Traditional | PDF ↗ |
| K072961 | LOTUS ULTRASONIC SYSTEM FOR CEMENTED IMPLANT EXTRACTION (USCIX) | Sra Developments, Ltd. | 2007-12-19 | Traditional | PDF ↗ |
| K051053 | OSCAR, MODEL OE3000DB | Orthosonics, Ltd. | 2005-07-21 | Traditional | PDF ↗ |
| K031280 | ULTRA-DRIVE 3 | Biomet, Inc. | 2003-09-22 | Traditional | PDF ↗ |
| K022729 | VENTED CEMENT RESTRICTOR | Amedica Corp. | 2002-11-14 | Traditional | PDF ↗ |
| K002484 | EMS SWISS ORTHOCLAST CHISELS FOR NON-CEMENTED PROSTHESIS REMOVAL | Electro Medical Systems SA | 2000-10-04 | Traditional | PDF ↗ |
| K961725 | OSCAR ORTHOSONICS SYSTEM FOR CEMENTED ARTHROPLASTY REVISION | C.L. Mcintosh & Assoc., Inc. | 1996-08-01 | Traditional | PDF ↗ |
| K930109 | KOMET MEDICAL SURGICAL POWER ACCESORIES | Brassler USA | 1993-08-25 | Traditional | PDF ↗ |
| K912931 | ITM SONIC SURGERY SYSTEM | Buckman Co., Inc. | 1991-10-03 | Traditional | PDF ↗ |
| K911548 | ACRYL-X SYSTEM TM | Sonokinetics, Inc. | 1991-06-28 | Traditional | PDF ↗ |
| K905451 | SYSTEM TEN, MODEL 100 SURGERY SYST/ORTHOPAEDIC USE | Advanced Osseous Technologies | 1991-03-05 | Traditional | PDF ↗ |
| K900003 | SYSTEM TEN MODEL 100 SURGICAL SYSTEM | Advanced Osseous Technologies | 1990-03-16 | Traditional | PDF ↗ |
| K891408 | MODIFIED PROFILE HIP ACETABULAR PROSTHESIS | Depuy, Inc. | 1989-06-12 | Traditional | PDF ↗ |
| K862504 | ACE MOS SAW AND THE ACE MOS SPINE SAW | Buckman Co., Inc. | 1986-08-07 | Traditional | PDF ↗ |
| K800501 | PFIZER/AS&E 0450 LOCALIZER | Pfizer Medical Systems, Inc. | 1980-04-10 | Traditional | PDF ↗ |
Product code JDX · Class II · Orthopedic. Data: openFDA.