XD880A Ultrasonic Osteotomy Surgical System
FDA 510(k) K172464 · Morley Research Consortium
510(k) numberK172464
Submission
- Device name
- XD880A Ultrasonic Osteotomy Surgical System
- Applicant
- Morley Research Consortium
Atlanta, GA, US - Received
- August 14, 2017
- Decision date
- April 24, 2018
- 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 |
| 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 |
| K051053 | Oscar, Model OE3000DBJDX · Traditional | Orthosonics, Ltd. | 07/21/2005SE |
Questions and answers
When was XD880A Ultrasonic Osteotomy Surgical System cleared by the FDA?
XD880A Ultrasonic Osteotomy Surgical System (K172464) received a 510(k) decision of Substantially Equivalent on April 24, 2018, 253 days after the submission was received.
What is the product code of K172464?
The FDA product code is JDX – Instrument, Surgical, Sonic And Accessory/Attachment, a Class II (moderate risk) device regulated under 21 CFR 888.4580.