FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
VARUS AND VALGUS LEG HOLDER
K Number: K873139
·
Decision Sep 16, 1987
Classifications
1
FEI Numbers
162
Registration Numbers
162
Same Product Code
60
Applicant Total
7
Review Days
37
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Basic Information
- Device Name
- VARUS AND VALGUS LEG HOLDER
- K Number
- K873139
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4950
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Leonard Medical, Inc.
- Date Received
- August 10, 1987
- Decision Date
- September 16, 1987
- Product Code
- FWZ
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| FWZ | Operating Room Accessories Table Tray | FDA class 1 | General, Plastic Surgery |
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Other Clearances by Leonard Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K951854 | LEONARD ARM - SUPPORT ARM - ENDOSCOPIC ACCESSORY | Jun 21, 1995 | Substantially Equivalent |
| K903536 | SMALL JOINT INSTRUMENTS (SCISSOR HANDLE) | Sep 6, 1990 | Substantially Equivalent |
| K895685 | SMALL JOINT HAND INSTRUMENTS | Oct 16, 1989 | Substantially Equivalent |
| K884308 | MANDIBLE MANIPULATOR | Mar 31, 1989 | Substantially Equivalent |
| K884314 | LEONARD MEDICAL 1.7MM ARTHROSCOPE | Mar 13, 1989 | Substantially Equivalent |
| K864117 | SUPPORT ARM | Nov 3, 1986 | Substantially Equivalent |