FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MCCONNELL REAMER GUIDE
K Number: K885100
·
Decision Jan 13, 1989
Classifications
1
FEI Numbers
354
Registration Numbers
354
Same Product Code
13
Applicant Total
16
Review Days
32
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Basic Information
- Device Name
- MCCONNELL REAMER GUIDE
- K Number
- K885100
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.4540
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Mcconnell Orthopedic
- Date Received
- December 12, 1988
- Decision Date
- January 13, 1989
- Product Code
- HTO
- 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 |
|---|---|---|---|
| HTO | Reamer | FDA class 1 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HTO), ordered by most recent decision date.
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FLEXIBLE INTRAMEDULLARY REAMER
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COMBINATION REAMER
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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 |
| K905564 | PREP AND OPERATING STAND | Feb 21, 1991 | 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 |