FDA product code HWM: Osteotome
HWM is the FDA product code for osteotome. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel. FDA has cleared 3 510(k) submissions under HWM, from 3 different applicants. The average 510(k) review took 18 days (median 13).
Classification
| Field | Value |
|---|---|
| Device name | Osteotome |
| Device class | Class I |
| Regulation | 21 CFR 878.4800 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HWM clearance
Top HWM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Micro-Aire Surgical Instruments, Inc. | 1 | 1987-12-02 |
| Buckman Co., Inc. | 1 | 1987-03-09 |
| Depuy, Inc. | 1 | 1977-09-28 |
Most recent HWM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K874503 | Micro-Aire Surgical Instruments, Inc. | MICRO-AIRE OSTEOTOME SYSTEM OR BONE HARVESTER | 1987-12-02 | 30 |
| K870780 | Buckman Co., Inc. | ACROMED WALLIE-HEINIG OSTEOTOMES | 1987-03-09 | 11 |
| K771744 | Depuy, Inc. | OSTEOTOMES FOR CUTTING BONH | 1977-09-28 | 13 |
Recalls for HWM devices
openFDA lists no recalls for product code HWM.
Frequently asked questions
What is FDA product code HWM?
HWM is the FDA product code for osteotome. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel.
What device class is HWM?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HWM?
Across 3 cleared submissions the average was 18 days from receipt to decision (median 13).
Which companies have the most HWM clearances?
Micro-Aire Surgical Instruments, Inc. (1); Buckman Co., Inc. (1); Depuy, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HWM
- Run a recall and safety report across every HWM manufacturer
- Watch product code HWM 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.
All General and Plastic Surgery product codes · FDA product code lookup · 510(k) database search · 510(k) review times