PIEZOSURGERY FLEX
FDA 510(k) clearance K132848 · decided 2013-11-29
Clearance details
- K-number
- K132848
- Device name
- PIEZOSURGERY FLEX
- Applicant
- Mectron S.P.A.
- Decision
- Substantially Equivalent
- Date received
- 2013-09-11
- Decision date
- 2013-11-29
- Days to decision
- 79 days
- Clearance type
- Traditional
- Product code
- JDX
- Device class
- 2
- Regulation number
- 888.4580
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Rome, IT
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Ultrasonic Osteotomy Surgical System (K201274) | Smtp Technology Co., Ltd. | 2021-02-19 |
| XD880A Ultrasonic Osteotomy Surgical System (K172464) | Morley Research Consortium | 2018-04-24 |
| PIEZOTOME M+, PIEZOTOME M+ Handpiece (K163610) | Satalec-Acteon Group | 2017-05-19 |
| PIEZOSURGERY PLUS (K153743) | Mectron S.P.A. | 2016-05-25 |
| PIEZOELECTRIC SYSTEM (K100410) | Satelec | 2010-04-28 |
| OSCAR 3 (K093805) | Orthosonics, Ltd. | 2010-02-19 |
| PIEZOSURGERY MEDICAL (K083284) | Piezosurgery S.R.L. | 2009-04-08 |
| OSCAR BONE RESECTOR (K083830) | Orthosonics, Ltd. | 2009-03-20 |
| LOTUS ULTRASONIC SYSTEM FOR CEMENTED IMPLANT EXTRACTION (USCIX) (K072961) | Sra Developments, Ltd. | 2007-12-19 |
| OSCAR, MODEL OE3000DB (K051053) | Orthosonics, Ltd. | 2005-07-21 |
| ULTRA-DRIVE 3 (K031280) | Biomet, Inc. | 2003-09-22 |
| VENTED CEMENT RESTRICTOR (K022729) | Amedica Corp. | 2002-11-14 |
Recalls involving this device
No recalls on record reference this clearance.