HXX — Screwdriver Class I
FDA product code HXX covers "Screwdriver", 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
- HXX
- 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 |
|---|---|---|---|
| K901166 | dalton technology | DALTON TECHNOLOGY FLEXIBLE SCREWDRIVER | June 13, 1990 |
| K873066 | buckman co | ACROMED SCREW DRIVER | September 2, 1987 |
| K872389 | med-tool | PRECISION SCREW DRIVER SET | July 15, 1987 |
| K862689 | w. l. gore and associates | 2.5MM HEX DRIVER/CURVE PASSER/BONE PUNCH/RASP | September 2, 1986 |