EMS Swiss Orthoclast Chisels for Non-Cemented Prosthesis Removal
FDA 510(k) K002484 · Electro Medical Systems SA
510(k) numberK002484
Submission
- Device name
- EMS Swiss Orthoclast Chisels for Non-Cemented Prosthesis Removal
- Applicant
- Electro Medical Systems SA
North Attleboro, MA, US - Received
- August 14, 2000
- Decision date
- October 4, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JDX – Instrument, Surgical, Sonic And Accessory/Attachment
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.4580
- Specialty
- Orthopedic
Other 510(k)s with product code JDX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K201274 | Ultrasonic Osteotomy Surgical SystemJDX · Traditional | Smtp Technology Co., Ltd. | 02/19/2021SE |
| K172464 | XD880A Ultrasonic Osteotomy Surgical SystemJDX · Traditional | Morley Research Consortium | 04/24/2018SE |
| K163610 | PIEZOTOME M+, PIEZOTOME M+ HandpieceJDX · Traditional | Satalec-Acteon Group | 05/19/2017SE |
| K153743 | Piezosurgery PlusJDX · Traditional | Mectron S.P.A. | 05/25/2016SE |
| K132848 | Piezosurgery FlexJDX · Traditional | Mectron S.P.A. | 11/29/2013SE |
| K100410 | Piezoelectric SystemJDX · Traditional | Satelec | 04/28/2010SE |
| K093805 | Oscar 3JDX · Traditional | Orthosonics, Ltd. | 02/19/2010SE |
| K083284 | Piezosurgery MedicalJDX · Traditional | Piezosurgery S.R.L. | 04/08/2009SE |
| K083830 | Oscar Bone ResectorJDX · Traditional | Orthosonics, Ltd. | 03/20/2009SE |
| K072961 | Lotus Ultrasonic System for Cemented Implant Extraction (Uscix)JDX · Traditional | Sra Developments, Ltd. | 12/19/2007SE |
More from Sra Developments, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K022328 | EMS Piezon Master 600ELC · Special | 08/13/2002SE |
| K022119 | EMS Air-Flow Handy 2 Dental HandpieceEFB · Special | 07/25/2002SE |
| K012445 | EMS Swiss Lithoclast Master (A.K.A. Swiss Lithoclast Ultra)FFK · Special | 08/24/2001SE |
| K991857 | Airflow HandyEFB · Traditional | 10/07/1999SE |
| K992251 | Swiss Lithoclast Multipurpose ProbeFFK · Special | 07/27/1999SE |
| K965203 | Radx SystemEHD · Traditional | 03/17/1997SE |
| K963285 | EMS Swiss Lithoclast LithotripterFFK · Traditional | 02/13/1997SE |
| K964111 | Lithovac Suction/Aspiration ProbeKQT · Traditional | 12/16/1996SE |
| K953026 | MinipiezonELC · Traditional | 08/28/1995SE |
| K951531 | Swiss Lithoclast LithotripterFFK · Traditional | 08/24/1995SE |
Questions and answers
When was EMS Swiss Orthoclast Chisels for Non-Cemented Prosthesis Removal cleared by the FDA?
EMS Swiss Orthoclast Chisels for Non-Cemented Prosthesis Removal (K002484) received a 510(k) decision of Substantially Equivalent on October 4, 2000, 51 days after the submission was received.
What is the product code of K002484?
The FDA product code is JDX – Instrument, Surgical, Sonic And Accessory/Attachment, a Class II (moderate risk) device regulated under 21 CFR 888.4580.