Twister, Wire
A wire twister is a handheld orthopedic instrument used to twist and tighten cerclage wires or suture wires to achieve the desired tension and secure fixation around bone or tissue. It is classified as an FDA Class 1 device under 21 CFR 888.4540, indicating minimal risk subject to general controls. Product code HXS falls under the Orthopedic medical specialty.
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Basic Information
- Product Code
- HXS
- 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 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 117 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 117 registration numbers. Click on an entry to view related FDA registrations.