FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PREP AND OPERATING STAND
K Number: K905564
·
Decision Feb 21, 1991
Classifications
1
FEI Numbers
162
Registration Numbers
162
Same Product Code
60
Applicant Total
16
Review Days
71
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Basic Information
- Device Name
- PREP AND OPERATING STAND
- K Number
- K905564
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4950
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Mcconnell Orthopedic
- Date Received
- December 12, 1990
- Decision Date
- February 21, 1991
- 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 Mcconnell Orthopedic
| K Number | Device Name | ||
|---|---|---|---|
| K910974 | MCCONNELL SHOULDER BRACE | Mar 21, 1991 | Substantially Equivalent |
| K905565 | LATERAL BUTTRESS SUPPORT | Feb 21, 1991 | Substantially Equivalent |
| K885100 | MCCONNELL REAMER GUIDE | Jan 13, 1989 | Substantially Equivalent |
| K871839 | MCCONNELL ORTHOPEDIC PELVIC CALIPER SUPPORT | May 26, 1987 | Substantially Equivalent |
| K871821 | MCCONNELL ORTHOPEDIC POSTERIOR BODY SUPPORT | May 26, 1987 | Substantially Equivalent |
| K871824 | MCCONNELL ORTHOPEDIC SUSPENSION SYSTEM | May 26, 1987 | Substantially Equivalent |
| K871822 | MCCONNELL ORTHOPEDIC U-HOOK ASSEMBLY | May 26, 1987 | Substantially Equivalent |
| K871820 | MCCONNELL ORTHOPEDIC ANTERIOR TORSO-ARM SUPPORT | May 26, 1987 | Substantially Equivalent |
| K871823 | MCCONNELL ORTHOPEDIC TIBIAL POSITIONER | May 26, 1987 | Substantially Equivalent |
| K871840 | MCCONNELL ORTHOPEDIC ANKLE POSITIONER | May 26, 1987 | Substantially Equivalent |