Wrench
An orthopedic wrench is a handheld instrument used during surgery to tighten, loosen, or torque nuts, bolts, or other hardware components of fixation devices and implant systems. It is classified as an FDA Class 1 device under 21 CFR 888.4540, indicating low risk and general controls only. Product code HXC falls under the Orthopedic medical specialty.
Research product code HXC in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- HXC
- 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 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K180092 | Intellitorq | Mar 08, 2018 | Substantially Equivalent | Gauthier Biomedical, Inc. |
| K874359 | ADJUSTABLE WRENCHES | Nov 23, 1987 | Substantially Equivalent | Med-Tool, Inc. |
| K874358 | COMBINATION WRENCHES | Nov 23, 1987 | Substantially Equivalent | Med-Tool, Inc. |
| K870053 | TORQUEDRIVER WRENCH | Mar 11, 1987 | Substantially Equivalent | Jerome Medical |
| K813067 | SPINAL WRENCH | Nov 24, 1981 | Substantially Equivalent | Twin City Surgical, Inc. |
| K791073 | WRENCH | Jun 20, 1979 | Substantially Equivalent | Truth, Inc. |
FEI Numbers
This FDA classification entry is associated with 266 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 266 registration numbers. Click on an entry to view related FDA registrations.