FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACRYL-X II SYSTEM
K Number: K930629
·
Decision Jan 21, 1994
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
6
Applicant Total
3
Review Days
347
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 II SYSTEM
- K Number
- K930629
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.4580
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sonokinetics, Inc.
- Date Received
- February 8, 1993
- Decision Date
- January 21, 1994
- Product Code
- LZV
- 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 |
|---|---|---|---|
| LZV | System, Cement Removal Extraction | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LZV), ordered by most recent decision date.
OSCAR, MODEL OE3000
FDA 510(k)
FDA Class 2
·Orthopedic
STRYKER CEMENT REMOVAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ORIGIN(TM) CEMENT EXTRACT SYST STD-PR/SPL-PR KITS
FDA 510(k)
FDA Class 2
·Orthopedic
PROSTHETIC CEMENT REMOVER
FDA 510(k)
FDA Class 2
·Orthopedic
IMPLANT TECHNOLOGY BONE CEMENT EXTRACTOR
FDA 510(k)
FDA Class 2
·Orthopedic
PROSTHETIC CEMENT REMOVER
FDA 510(k)
FDA Class 2
·Orthopedic