Screwdriver
An orthopedic screwdriver is a handheld instrument used to insert, tighten, or remove bone screws and other threaded fixation hardware during orthopedic surgical procedures. It is classified as an FDA Class 1 device under 21 CFR 888.4540, indicating low risk and general controls only. Product code HXX falls under the Orthopedic medical specialty.
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Basic Information
- Product Code
- HXX
- Device Class
- FDA class 1
- Regulation Number
- 888.4540
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K901166 | DALTON TECHNOLOGY FLEXIBLE SCREWDRIVER | Jun 13, 1990 | Substantially Equivalent | Dalton Technology, Inc. |
| K873066 | ACROMED SCREW DRIVER | Sep 02, 1987 | Substantially Equivalent | Buckman Co., Inc. |
| K872389 | PRECISION SCREW DRIVER SET | Jul 15, 1987 | Substantially Equivalent | Med-Tool, Inc. |
| K862689 | 2.5MM HEX DRIVER/CURVE PASSER/BONE PUNCH/RASP | Sep 02, 1986 | Substantially Equivalent | W. L. Gore & Associates, Inc. |
FEI Numbers
This FDA classification entry is associated with 465 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 465 registration numbers. Click on an entry to view related FDA registrations.