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 |
|---|---|---|---|
| 00199150081875 | Medtronic Reusable Instruments | MEDTRONIC SOFAMOR DANEK, INC. | 2026-07-19 |
| 00199150072323 | Medtronic Reusable Instruments | MEDTRONIC SOFAMOR DANEK, INC. | 2026-07-19 |
| 07290019361336 | OSSIO® Inserter | OSSIO LTD | 2026-07-19 |
| 18257200163724 | PILLAR SA Ti | Orthofix US LLC | 2026-07-17 |
| 18257200163847 | PILLAR SA Ti | Orthofix US LLC | 2026-07-17 |
| 18257200163830 | PILLAR SA Ti | Orthofix US LLC | 2026-07-17 |
| 18257200163731 | PILLAR SA Ti | Orthofix US LLC | 2026-07-17 |
| 18257200142620 | Firebird SI Fusion | Orthofix US LLC | 2026-07-17 |
| 18257200136285 | Firebird SI Fusion | Orthofix US LLC | 2026-07-17 |
| 18257200131181 | Firebird SI Fusion | Orthofix US LLC | 2026-07-17 |
| 18257200051427 | REMOVAL INSTRUMENTS | Orthofix US LLC | 2026-07-17 |
| 18257200051410 | PROVIEW | Orthofix US LLC | 2026-07-17 |
| 18257200051311 | REMOVAL INSTRUMENTS | Orthofix US LLC | 2026-07-17 |
| 18257200051304 | REMOVAL INSTRUMENTS | Orthofix US LLC | 2026-07-17 |
| 00763000913267 | Medtronic Reusable Instruments & Accessories | MEDTRONIC SOFAMOR DANEK, INC. | 2026-07-17 |
| 08800322758274 | 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 |
| 08800322758175 | Anyplus ll Spinal Fixation System | GS Medical Co., Ltd. | 2026-04-21 |
| 08800322708224 | 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 |
| 08809885715441 | Anyplus II Spinal Fixation System | GS Medical Co., Ltd. | 2025-03-17 |
| 08809695639999 | Anyplus II Spinal Fixation System | GS Medical Co., Ltd. | 2025-03-17 |
| 08800104099847 | Anyplus II Spinal Fixation System | GS Medical Co., Ltd. | 2025-03-17 |
| 08800104099731 | Anyplus II Spinal Fixation System | GS Medical Co., Ltd. | 2025-03-17 |
| 08800104097973 | Anyplus II Spinal Fixation System | GS Medical Co., Ltd. | 2025-03-17 |
| 08800104097959 | Anyplus II Spinal Fixation System | GS Medical Co., Ltd. | 2025-03-17 |
| 08809885749996 | Anyplus II Spinal Fixation System | GS Medical Co., Ltd. | 2025-03-17 |
| 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 |
| 08806162199178 | Anyplus II Spinal Fixation System | GS Medical Co., Ltd. | 2025-03-17 |