FDA product code HWP: Punch, Femoral Neck
HWP is the FDA product code for punch, femoral neck. It is a Class I device, regulated under 21 CFR 888.4540 and reviewed by the Orthopedic panel. FDA has cleared 1 510(k) submission under HWP. The average 510(k) review took 10 days (median 10).
Classification
| Field | Value |
|---|---|
| Device name | Punch, Femoral Neck |
| Device class | Class I |
| Regulation | 21 CFR 888.4540 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HWP clearance
Top HWP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Warsaw Orthopedic, Inc. | 1 | 1987-03-13 |
Most recent HWP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K870846 | Warsaw Orthopedic, Inc. | SCHULTZ MP COMPONENT PUNCH | 1987-03-13 | 10 |
Recalls for HWP devices
openFDA lists no recalls for product code HWP.
Frequently asked questions
What is FDA product code HWP?
HWP is the FDA product code for punch, femoral neck. It is a Class I device, regulated under 21 CFR 888.4540 and reviewed by the Orthopedic panel.
What device class is HWP?
Class I, regulation 21 CFR 888.4540. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HWP?
Across 1 cleared submissions the average was 10 days from receipt to decision (median 10).
Which companies have the most HWP clearances?
Warsaw Orthopedic, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HWP
- Run a recall and safety report across every HWP manufacturer
- Watch product code HWP for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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