FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACRYL-X SYSTEM TM
K Number: K911548
·
Decision Jun 28, 1991
Classifications
1
FEI Numbers
36
Registration Numbers
37
Same Product Code
22
Applicant Total
3
Review Days
81
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ACRYL-X SYSTEM TM
- K Number
- K911548
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.4580
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Sonokinetics, Inc.
- Date Received
- April 8, 1991
- Decision Date
- June 28, 1991
- 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 PLUS
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