Passer, Wire, Orthopedic
An orthopedic wire passer is a slender, handheld instrument designed to thread or guide surgical wire around bone, through tunnels, or around fixation hardware during cerclage wiring or suture passing procedures. It is classified as an FDA Class 1 device under 21 CFR 888.4540, indicating low risk and general controls only. Product code HXI falls under the Orthopedic medical specialty.
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Basic Information
- Product Code
- HXI
- 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 3 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 152 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 152 registration numbers. Click on an entry to view related FDA registrations.