JDX — Instrument, Surgical, Sonic And Accessory/Attachment Class II
FDA product code JDX covers "Instrument, Surgical, Sonic And Accessory/Attachment", a Class II medical device regulated under 21 CFR 888.4580. Submissions are reviewed by the Orthopedic panel. At least 20 recent 510(k) clearances have been granted under this product code.
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-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K201274 | smtp technology co | Ultrasonic Osteotomy Surgical System | February 19, 2021 |
| K172464 | morley research consortium | XD880A Ultrasonic Osteotomy Surgical System | April 24, 2018 |
| K163610 | satalec-acteon group | PIEZOTOME M+, PIEZOTOME M+ Handpiece | May 19, 2017 |
| K153743 | mectron | PIEZOSURGERY PLUS | May 25, 2016 |
| K132848 | mectron | PIEZOSURGERY FLEX | November 29, 2013 |
| K100410 | satelec | PIEZOELECTRIC SYSTEM | April 28, 2010 |
| K093805 | orthosonics | OSCAR 3 | February 19, 2010 |
| K083284 | piezosurgery | PIEZOSURGERY MEDICAL | April 8, 2009 |
| K083830 | orthosonics | OSCAR BONE RESECTOR | March 20, 2009 |
| K072961 | sra developments | LOTUS ULTRASONIC SYSTEM FOR CEMENTED IMPLANT EXTRACTION (USCIX) | December 19, 2007 |
| K051053 | orthosonics | OSCAR, MODEL OE3000DB | July 21, 2005 |
| K031280 | biomet | ULTRA-DRIVE 3 | September 22, 2003 |
| K022729 | amedica | VENTED CEMENT RESTRICTOR | November 14, 2002 |
| K002484 | electro medical systems | EMS SWISS ORTHOCLAST CHISELS FOR NON-CEMENTED PROSTHESIS REMOVAL | October 4, 2000 |
| K961725 | c.l. mcintosh and assoc | OSCAR ORTHOSONICS SYSTEM FOR CEMENTED ARTHROPLASTY REVISION | August 1, 1996 |
| K930109 | brassler usa | KOMET MEDICAL SURGICAL POWER ACCESORIES | August 25, 1993 |
| K912931 | buckman co | ITM SONIC SURGERY SYSTEM | October 3, 1991 |
| K911548 | sonokinetics | ACRYL-X SYSTEM TM | June 28, 1991 |
| K905451 | advanced osseous technologies | SYSTEM TEN, MODEL 100 SURGERY SYST/ORTHOPAEDIC USE | March 5, 1991 |
| K900003 | advanced osseous technologies | SYSTEM TEN MODEL 100 SURGICAL SYSTEM | March 16, 1990 |