Product code HXX
- Device name
- Screwdriver
- Medical specialty
- Orthopedic
- Device class
- 1
- Regulation number
- 888.4540
- Review panel
- OR
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K901166 | DALTON TECHNOLOGY FLEXIBLE SCREWDRIVER | Dalton Technology, Inc. | 1990-06-13 |
| K873066 | ACROMED SCREW DRIVER | Buckman Co., Inc. | 1987-09-02 |
| K872389 | PRECISION SCREW DRIVER SET | Med-Tool, Inc. | 1987-07-15 |
| K862689 | 2.5MM HEX DRIVER/CURVE PASSER/BONE PUNCH/RASP | W. L. Gore & Associates, Inc. | 1986-09-02 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00841732142442 | GENERIC Surgical Instruments | CTL Medical Corporation | 2025-03-31 |
| 00841732142435 | GENERIC Surgical Instruments | CTL Medical Corporation | 2025-03-31 |
| 00841732142428 | GENERIC Surgical Instruments | CTL Medical Corporation | 2025-03-31 |
| 00841732142312 | GENERIC Surgical Instruments | CTL Medical Corporation | 2025-03-31 |
| 00841732142190 | GENERIC Surgical Instruments | CTL Medical Corporation | 2025-03-28 |
| 00841732162792 | VALEO | CTL Medical Corporation | 2024-10-02 |
| 00818069019976 | Tecomet | TECOMET INC. | 2020-10-09 |
| 00818069019969 | Tecomet | TECOMET INC. | 2020-10-09 |
| 00818069019839 | Tecomet | TECOMET INC. | 2020-10-09 |
| 00818069019679 | Tecomet | TECOMET INC. | 2020-10-09 |
| 00818069019662 | Tecomet | TECOMET INC. | 2020-10-09 |
| 00818069019655 | Tecomet | TECOMET INC. | 2020-10-09 |
| 00818069019631 | Tecomet | TECOMET INC. | 2020-10-09 |
| 00818069015886 | Tecomet | TECOMET INC. | 2020-10-08 |
| 00818069019051 | Tecomet | TECOMET INC. | 2020-10-08 |
| 00818069015893 | Tecomet | TECOMET INC. | 2020-10-08 |
| 00818069015879 | Tecomet | TECOMET INC. | 2020-10-08 |
| 00818069015800 | Tecomet | TECOMET INC. | 2020-10-08 |
| 00818069015787 | Tecomet | TECOMET INC. | 2020-10-08 |
| 00818069015770 | Tecomet | TECOMET INC. | 2020-10-08 |
| 00818069015732 | Tecomet | TECOMET INC. | 2020-10-08 |
| 00818069015725 | Tecomet | TECOMET INC. | 2020-10-08 |
| 00818069015718 | Tecomet | TECOMET INC. | 2020-10-08 |
| 00818069015695 | Tecomet | TECOMET INC. | 2020-10-08 |
| 00818069015640 | Tecomet | TECOMET INC. | 2020-10-08 |
| 00818069015633 | Tecomet | TECOMET INC. | 2020-10-08 |
| 00818069015329 | Tecomet | TECOMET INC. | 2020-10-08 |
| 00818069015312 | Tecomet | TECOMET INC. | 2020-10-08 |
| 00818069015305 | Tecomet | TECOMET INC. | 2020-10-08 |
| 00818069015299 | Tecomet | TECOMET INC. | 2020-10-08 |