Piezosurgery Flex
FDA 510(k) K132848 · Mectron S.P.A.
510(k) numberK132848
Submission
- Device name
- Piezosurgery Flex
- Applicant
- Mectron S.P.A.
Rome, IT - Received
- September 11, 2013
- Decision date
- November 29, 2013
- 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
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| K163610 | PIEZOTOME M+, PIEZOTOME M+ HandpieceJDX · Traditional | Satalec-Acteon Group | 05/19/2017SE |
| K153743 | Piezosurgery PlusJDX · Traditional | Mectron S.P.A. | 05/25/2016SE |
| 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 |
More from Orthosonics, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K251425 | turbodent touchKOJ · Traditional | 05/09/2025SE |
| K242432 | MT-BoneDZI · Traditional | 08/19/2024SE |
| K231391 | Combi TouchELC · Traditional | 05/15/2023SE |
| K171326 | Piezosurgery WhiteDZI · Traditional | 04/13/2018SE |
| K171958 | Piezosurgery Touch, Piezosurgery WhiteDZI · Traditional | 01/12/2018SE |
| K153743 | Piezosurgery PlusJDX · Traditional | 05/25/2016SE |
| K151248 | Piezosurgery WhiteDZI · Traditional | 09/04/2015SE |
| K151023 | Compact Piezo LEDELC · Traditional | 08/05/2015SE |
| K140965 | Multipiezo Pro, MultipiezoELC · Traditional | 08/20/2014SE |
| K122322 | Piezosurgery TouchDZI · Traditional | 12/06/2012SE |
Questions and answers
When was Piezosurgery Flex cleared by the FDA?
Piezosurgery Flex (K132848) received a 510(k) decision of Substantially Equivalent on November 29, 2013, 79 days after the submission was received.
What is the product code of K132848?
The FDA product code is JDX – Instrument, Surgical, Sonic And Accessory/Attachment, a Class II (moderate risk) device regulated under 21 CFR 888.4580.