HWR — Driver, Prosthesis Class I
FDA product code HWR covers "Driver, Prosthesis", a Class I medical device regulated under 21 CFR 888.4540. Submissions are reviewed by the Orthopedic panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HWR
- Device Class
- Class I
- Regulation Number
- 888.4540
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K915776 | Kim-Med | KNEE PROSTHESIS DRIVER | Jun 11, 1992 |
| K875054 | Buckman Co | ACROMED ADS BONE NAIL DRIVER | Jan 28, 1988 |
| K870848 | Warsaw Orthopedic | SCHULTZ METACARPAL COMPONENT DRIVER | Mar 13, 1987 |
| K870847 | Warsaw Orthopedic | SCHULTZ PHALANGEAL COMPONENT DRIVER | Mar 13, 1987 |