510(k) K153743
- Device
- PIEZOSURGERY PLUS
- Applicant
- MECTRON SPA
- 510(k) number
- K153743
- Product code
- JDX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-05-25
- Date received
- 2015-12-28
- Regulation
- 888.4580
- Classification name
- Instrument, Surgical, Sonic And Accessory/attachment
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ZUNINO FRANCO
- Address
- Via Loreto 15 Carasco IT 16042 16042
FDA Registration Numbers#
- 3024490294
- 3011774865
- 3010363503
- 3015207155
- 8043792
- 3009352510
- 3005282635
- 2183449
- 3021599290
- 2243757
- 9681479
- 1450662
- 9680825
- 3002806603
- 8044015
- 3030446516
- 1424263
- 3010027944
- 3029901716
- 3030183061
- 3010462278
- 3010386387
- 1825034
- 3011300255
- 3013176080
- 3027339887
- 3012663306
- 3003933619
- 3010356635
- 3035366890
- 3017619615
- 3008868758
- 3014302784
- 3007279848
- 3041274936
Source Documents#
Other 510(k) Records For Product Code JDX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K201274 | Ultrasonic Osteotomy Surgical System | Smtp Technology Co., Ltd. | 2021-02-19 |
| K172464 | XD880A Ultrasonic Osteotomy Surgical System | Morley Research Consortium | 2018-04-24 |
| K163610 | PIEZOTOME M+, PIEZOTOME M+ Handpiece | Satalec-Acteon Group | 2017-05-19 |
| K132848 | PIEZOSURGERY FLEX | Mectron S.P.A. | 2013-11-29 |
| K100410 | PIEZOELECTRIC SYSTEM | Satelec | 2010-04-28 |
| K093805 | OSCAR 3 | Orthosonics, Ltd. | 2010-02-19 |
| K083284 | PIEZOSURGERY MEDICAL | Piezosurgery S.R.L. | 2009-04-08 |
| K083830 | OSCAR BONE RESECTOR | Orthosonics, Ltd. | 2009-03-20 |
| K072961 | LOTUS ULTRASONIC SYSTEM FOR CEMENTED IMPLANT EXTRACTION (USCIX) | Sra Developments, Ltd. | 2007-12-19 |
| K051053 | OSCAR, MODEL OE3000DB | Orthosonics, Ltd. | 2005-07-21 |
| K031280 | ULTRA-DRIVE 3 | Biomet, Inc. | 2003-09-22 |
| K022729 | VENTED CEMENT RESTRICTOR | Amedica Corp. | 2002-11-14 |
| K002484 | EMS SWISS ORTHOCLAST CHISELS FOR NON-CEMENTED PROSTHESIS REMOVAL | Electro Medical Systems SA | 2000-10-04 |
| K961725 | OSCAR ORTHOSONICS SYSTEM FOR CEMENTED ARTHROPLASTY REVISION | C.L. Mcintosh & Assoc., Inc. | 1996-08-01 |
| K930109 | KOMET MEDICAL SURGICAL POWER ACCESORIES | Brassler USA | 1993-08-25 |
Legacy Summary#
summary
FDA Review#
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