FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PRECISION SCREW DRIVER SET
K Number: K872389
·
Decision Jul 15, 1987
Classifications
1
FEI Numbers
465
Registration Numbers
465
Same Product Code
3
Applicant Total
28
Review Days
26
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Basic Information
- Device Name
- PRECISION SCREW DRIVER SET
- K Number
- K872389
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.4540
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Med-Tool, Inc.
- Date Received
- June 19, 1987
- Decision Date
- July 15, 1987
- Product Code
- HXX
- 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 |
|---|---|---|---|
| HXX | Screwdriver | FDA class 1 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HXX), ordered by most recent decision date.
DALTON TECHNOLOGY FLEXIBLE SCREWDRIVER
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FDA Class 1
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ACROMED SCREW DRIVER
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FDA Class 1
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2.5MM HEX DRIVER/CURVE PASSER/BONE PUNCH/RASP
FDA 510(k)
FDA Class 1
·Orthopedic
Other Clearances by Med-Tool, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K874357 | TAPERED PUNCH | Nov 23, 1987 | Substantially Equivalent |
| K874356 | PIN PUNCH | Nov 23, 1987 | Substantially Equivalent |
| K874359 | ADJUSTABLE WRENCHES | Nov 23, 1987 | Substantially Equivalent |
| K874358 | COMBINATION WRENCHES | Nov 23, 1987 | Substantially Equivalent |
| K872388 | NAIL SET | Jul 23, 1987 | Substantially Equivalent |
| K872385 | VICE OR BENCH VICE | Jul 16, 1987 | Substantially Equivalent |
| K872387 | STANDARD SCREW DRIVER | Jul 16, 1987 | Substantially Equivalent |
| K872384 | SIDE CUTTING PARALLEL ACTION PLIERS | Jul 2, 1987 | Substantially Equivalent |
| K872386 | C CLAMP | Jul 2, 1987 | Substantially Equivalent |
| K864018 | HACKSAW | Oct 30, 1986 | Substantially Equivalent |