FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AGEE EXTERNAL FIXATOR
K Number: K842493
·
Decision Feb 13, 1985
Classifications
1
FEI Numbers
68
Registration Numbers
68
Same Product Code
84
Applicant Total
1
Review Days
232
Basic Information
- Device Name
- AGEE EXTERNAL FIXATOR
- K Number
- K842493
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- THE HAND BIOMECHANICS RESEARCH LABORATORY
- Date Received
- June 26, 1984
- Decision Date
- February 13, 1985
- Product Code
- JEC
- 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 |
|---|---|---|---|
| JEC | Component, Traction, Invasive | FDA class 2 | Orthopedic |
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