Product Code: HXE FDA class 1 21 CFR 888.4540

Fork

Orthopedic

An orthopedic fork is a pronged handheld instrument used during joint surgery to retract soft tissue, guide instruments, or manipulate implant components into position. It is classified as an FDA Class 1 device under 21 CFR 888.4540, indicating low risk and general controls only. Product code HXE falls under the Orthopedic medical specialty.

510(k)s
0
FEI Numbers
44
Registration Numbers
44
Unique Applicants
0
Years Active

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Basic Information

Product Code
HXE
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

FEI Numbers

This FDA classification entry is associated with 44 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 44 registration numbers. Click on an entry to view related FDA registrations.