FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
A HOOK DRIVER
K Number: K820660
·
Decision Mar 19, 1982
Classifications
1
FEI Numbers
321
Registration Numbers
321
Same Product Code
429
Applicant Total
6
Review Days
9
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Basic Information
- Device Name
- A HOOK DRIVER
- K Number
- K820660
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3050
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Twin City Surgical, Inc.
- Date Received
- March 10, 1982
- Decision Date
- March 19, 1982
- Product Code
- KWP
- 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 |
|---|---|---|---|
| KWP | Appliance, Fixation, Spinal Interlaminal | FDA class 2 | Orthopedic |
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Other Clearances by Twin City Surgical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K870767 | THE (CROM) TESTER | Mar 17, 1987 | Substantially Equivalent |
| K861632 | SIMS CHAIR | May 27, 1986 | Substantially Equivalent |
| K830585 | ANVIL RETRACTOR | May 27, 1983 | Substantially Equivalent |
| K820659 | A CALIPER | Mar 19, 1982 | Substantially Equivalent |
| K813067 | SPINAL WRENCH | Nov 24, 1981 | Substantially Equivalent |