Osteotome
An osteotome is a flat-bladed, chisel-like surgical instrument used in orthopedic and plastic surgery to cut or shape bone, typically driven by a mallet, and employed in procedures such as osteotomies and nasal or facial bone reconstruction. It is classified as an FDA Class 1 device under 21 CFR 878.4800, indicating minimal risk subject to general controls. Product code HWM falls under the General and Plastic Surgery medical specialty.
Research product code HWM 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
- HWM
- Device Class
- FDA class 1
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K874503 | MICRO-AIRE OSTEOTOME SYSTEM OR BONE HARVESTER | Dec 02, 1987 | Substantially Equivalent | Micro-Aire Surgical Instruments, Inc. |
| K870780 | ACROMED WALLIE-HEINIG OSTEOTOMES | Mar 09, 1987 | Substantially Equivalent | Buckman Co., Inc. |
| K771744 | OSTEOTOMES FOR CUTTING BONH | Sep 28, 1977 | Substantially Equivalent | Depuy, Inc. |
FEI Numbers
This FDA classification entry is associated with 258 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 258 registration numbers. Click on an entry to view related FDA registrations.