FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
PIEZOSURGERY PLUS
K Number: K153743
·
Decision May 25, 2016
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
22
Applicant Total
4
Review Days
149
Basic Information
- Device Name
- PIEZOSURGERY PLUS
- K Number
- K153743
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.4580
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MECTRON SPA
- Date Received
- December 28, 2015
- Decision Date
- May 25, 2016
- Product Code
- JDX
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JDX | Instrument, Surgical, Sonic And Accessory/Attachment | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JDX), ordered by most recent decision date.
Ultrasonic Osteotomy Surgical System
FDA 510(k)
FDA Class 2
·Orthopedic
XD880A Ultrasonic Osteotomy Surgical System
FDA 510(k)
FDA Class 2
·Orthopedic
PIEZOTOME M+, PIEZOTOME M+ Handpiece
FDA 510(k)
FDA Class 2
·Orthopedic
PIEZOSURGERY FLEX
FDA 510(k)
FDA Class 2
·Orthopedic
PIEZOELECTRIC SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
OSCAR 3
FDA 510(k)
FDA Class 2
·Orthopedic