Product Code: HXZ FDA class 1 21 CFR 888.4540

Cutter, Wire

Orthopedic

A wire cutter is a handheld orthopedic instrument used to cut surgical wires, cerclage cables, or suture wires to the required length during fixation procedures or during hardware removal. It is classified as an FDA Class 1 device under 21 CFR 888.4540, indicating low risk and general controls only. Product code HXZ falls under the Orthopedic medical specialty.

510(k)s
1
FEI Numbers
249
Registration Numbers
249
Unique Applicants
1
Years Active

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Basic Information

Product Code
HXZ
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 1 510(k) clearance via K numbers.

K Number Device Name
K873715 BONE PIN CUTTER 18

FEI Numbers

This FDA classification entry is associated with 249 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 249 registration numbers. Click on an entry to view related FDA registrations.