FDA product code HWK: Trephine
HWK is the FDA product code for trephine. 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 HWK. The average 510(k) review took 90 days (median 90).
Classification
| Field | Value |
|---|---|
| Device name | Trephine |
| 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 HWK clearance
Top HWK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Concept, Inc. | 1 | 1985-07-02 |
Most recent HWK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K851339 | Concept, Inc. | PRECISION HARVEST & INLAY INSTRUMENT SET | 1985-07-02 | 90 |
Recalls for HWK devices
openFDA lists no recalls for product code HWK.
Frequently asked questions
What is FDA product code HWK?
HWK is the FDA product code for trephine. It is a Class I device, regulated under 21 CFR 888.4540 and reviewed by the Orthopedic panel.
What device class is HWK?
Class I, regulation 21 CFR 888.4540. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HWK?
Across 1 cleared submissions the average was 90 days from receipt to decision (median 90).
Which companies have the most HWK clearances?
Concept, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HWK
- Run a recall and safety report across every HWK manufacturer
- Watch product code HWK 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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