Product Code: HWP FDA class 1 21 CFR 888.4540

Punch, Femoral Neck

Orthopedic

A femoral neck punch is a handheld orthopedic instrument used to create a hole or starting point in the femoral neck during hip arthroplasty or fracture repair procedures. It is classified as an FDA Class 1 device under 21 CFR 888.4540, indicating low risk and general controls only. Product code HWP falls under the Orthopedic medical specialty.

510(k)s
1
FEI Numbers
48
Registration Numbers
48
Unique Applicants
1
Years Active

Research product code HWP in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Basic Information

Product Code
HWP
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

Loading...

Related 510(k) Clearances

This FDA classification is associated with 1 510(k) clearance via K numbers.

K Number Device Name
K870846 SCHULTZ MP COMPONENT PUNCH

FEI Numbers

This FDA classification entry is associated with 48 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 48 registration numbers. Click on an entry to view related FDA registrations.