Punch, Femoral Neck
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.
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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
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K870846 | SCHULTZ MP COMPONENT PUNCH | Mar 13, 1987 | Substantially Equivalent | Warsaw Orthopedic, Inc. |
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.