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 |
|---|---|---|---|
| 00199150081899 | Medtronic Reusable Instruments | MEDTRONIC SOFAMOR DANEK, INC. | 2026-07-10 |
| 00199150081882 | Medtronic Reusable Instruments | MEDTRONIC SOFAMOR DANEK, INC. | 2026-07-10 |
| 00842188132520 | Tools - Screws | Trimed, INC. | 2026-07-09 |
| 00842188132513 | Tools - Screws | Trimed, INC. | 2026-07-09 |
| 08800322708224 | Anyplus ll Spinal Fixation System | GS Medical Co., Ltd. | 2026-04-21 |
| 08800322758175 | Anyplus ll Spinal Fixation System | GS Medical Co., Ltd. | 2026-04-21 |
| 08800322758267 | Anyplus ll Spinal Fixation System | GS Medical Co., Ltd. | 2026-04-21 |
| 08800322758274 | Anyplus ll Spinal Fixation System | GS Medical Co., Ltd. | 2026-04-21 |
| 08809695589973 | PYXIS 3D Titanium Cervical Cage, Close | GS Medical Co., Ltd. | 2026-01-28 |
| 04719879398069 | Tandry Orthopedic Manual Surgical Instrument | MICROWARE PRECISION CO., LTD. | 2025-08-22 |
| 04719879398052 | Tandry Orthopedic Manual Surgical Instrument | MICROWARE PRECISION CO., LTD. | 2025-08-22 |
| 04719879398045 | Tandry Orthopedic Manual Surgical Instrument | MICROWARE PRECISION CO., LTD. | 2025-05-07 |
| 08809885717384 | Anyplus II Spinal Fixation System | GS Medical Co., Ltd. | 2025-03-17 |
| 08809885799779 | Anyplus II Spinal Fixation System | GS Medical Co., Ltd. | 2025-03-17 |
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| 08809695602139 | Anyplus II Spinal Fixation System | GS Medical Co., Ltd. | 2025-03-17 |
| 08806395499618 | Anyplus II Spinal Fixation System | GS Medical Co., Ltd. | 2025-03-17 |
| 00815362021460 | Slimplicity Anterior Cervical Plate System | PRECISION SPINE, INC. | 2019-04-01 |
| 10705034718040 | NA | SYNTHES (U.S.A.) LP | 2018-10-29 |
| 10705034712802 | NA | Synthes GmbH | 2016-12-31 |
| 10705034768939 | NA | Synthes GmbH | 2016-12-31 |
| 10705034768960 | Click'X | Synthes GmbH | 2016-12-31 |
| 10705034772608 | NA | Synthes GmbH | 2016-12-31 |