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 |
|---|---|---|---|
| 00824846003205 | Medtronic Reusable Instruments | MEDTRONIC SOFAMOR DANEK, INC. | 2026-07-26 |
| 00824846003199 | Medtronic Reusable Instruments | MEDTRONIC SOFAMOR DANEK, INC. | 2026-07-26 |
| 10887587078557 | NA | Synthes GmbH | 2026-07-24 |
| 10887587078564 | NA | Synthes GmbH | 2026-07-24 |
| 00888118154644 | LEVEL ONE, STERILE | KLS-Martin L.P. | 2026-07-21 |
| 00888118154651 | LEVEL ONE, STERILE | KLS-Martin L.P. | 2026-07-21 |
| 00888118154668 | LEVEL ONE, STERILE | KLS-Martin L.P. | 2026-07-21 |
| 00888118154675 | LEVEL ONE, STERILE | KLS-Martin L.P. | 2026-07-21 |
| 00888118154682 | LEVEL ONE, STERILE | KLS-Martin L.P. | 2026-07-21 |
| 00888118154699 | LEVEL ONE, STERILE | KLS-Martin L.P. | 2026-07-21 |
| 00888118154705 | LEVEL ONE, STERILE | KLS-Martin L.P. | 2026-07-21 |
| 00888118154712 | LEVEL ONE | KLS-Martin L.P. | 2026-07-21 |
| 00199150072323 | Medtronic Reusable Instruments | MEDTRONIC SOFAMOR DANEK, INC. | 2026-07-19 |
| 07290019361336 | OSSIO® Inserter | OSSIO LTD | 2026-07-19 |
| 00199150081875 | Medtronic Reusable Instruments | MEDTRONIC SOFAMOR DANEK, INC. | 2026-07-19 |
| 00763000913267 | Medtronic Reusable Instruments & Accessories | MEDTRONIC SOFAMOR DANEK, INC. | 2026-07-17 |
| 18257200051304 | REMOVAL INSTRUMENTS | Orthofix US LLC | 2026-07-17 |
| 18257200051311 | REMOVAL INSTRUMENTS | Orthofix US LLC | 2026-07-17 |
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| 18257200051427 | REMOVAL INSTRUMENTS | Orthofix US LLC | 2026-07-17 |
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| 18257200142620 | Firebird SI Fusion | Orthofix US LLC | 2026-07-17 |
| 18257200163724 | PILLAR SA Ti | Orthofix US LLC | 2026-07-17 |
| 18257200163731 | PILLAR SA Ti | Orthofix US LLC | 2026-07-17 |
| 18257200163830 | PILLAR SA Ti | Orthofix US LLC | 2026-07-17 |
| 18257200163847 | PILLAR SA Ti | Orthofix US LLC | 2026-07-17 |
| 00840019972918 | Reform Ti Modular | PRECISION SPINE, INC. | 2025-01-24 |
| 04038653106080 | AESCULAP | Aesculap AG | 2020-04-21 |
| 04038653105878 | AESCULAP | Aesculap AG | 2020-04-21 |