FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ARTHROSCOPIC ACL DRILL SYSTEM
K Number: K925986
·
Decision Mar 4, 1993
Classifications
1
FEI Numbers
368
Registration Numbers
368
Same Product Code
669
Applicant Total
181
Review Days
99
Basic Information
- Device Name
- ARTHROSCOPIC ACL DRILL SYSTEM
- K Number
- K925986
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.1100
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- ARTHREX, INC.
- Date Received
- November 25, 1992
- Decision Date
- March 4, 1993
- Product Code
- HRX
- 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 |
|---|---|---|---|
| HRX | Arthroscope | FDA class 2 | Orthopedic |
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