Product Code: HXN
FDA class 1
21 CFR 888.4540
Applier, Cerclage
Orthopedic
A cerclage applier is a handheld orthopedic instrument used to apply, tension, and secure cerclage wires or cables around bone to provide supplemental fixation in fracture repair or periprosthetic fixation procedures. It is classified as an FDA Class 1 device under 21 CFR 888.4540, indicating low risk and general controls only. Product code HXN falls under the Orthopedic medical specialty.
510(k)s
2
FEI Numbers
28
Registration Numbers
28
Unique Applicants
2
Years Active
19
Basic Information
- Product Code
- HXN
- Device Class
- FDA class 1
- Regulation Number
- 888.4540
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 4
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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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 28 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 28 registration numbers. Click on an entry to view related FDA registrations.