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 |
|---|---|---|---|
| 08800308486047 | INNOVERSE SPINAL SYSTEM | CG MedTech Co.,Ltd. | 2026-11-04 |
| 08800308486054 | INNOVERSE SPINAL SYSTEM | CG MedTech Co.,Ltd. | 2026-11-04 |
| 08809974816004 | Anyplus ll Spinal Fixation System | GS Medical Co., Ltd. | 2026-11-03 |
| 00841731133717 | REDEMPTION Beaming System | VILEX LLC | 2026-11-03 |
| 00841731133724 | REDEMPTION Beaming System | VILEX LLC | 2026-11-03 |
| 08800322759233 | Anyplus ll Spinal Fixation System | GS Medical Co., Ltd. | 2026-11-03 |
| 08800322759240 | Anyplus ll Spinal Fixation System | GS Medical Co., Ltd. | 2026-11-03 |
| 08809695602887 | Anyplus ll Spinal Fixation System | GS Medical Co., Ltd. | 2026-11-03 |
| 08809974815953 | Anyplus ll Spinal Fixation System | GS Medical Co., Ltd. | 2026-11-03 |
| B382SD91449311010 | Surgical Direct | Surgical Direct, Inc. | 2026-10-28 |
| 08800089487820 | Surgical Instrument | Jeil Medical Corporation | 2026-10-26 |
| 00190776436933 | Millennium | Avalign Technologies, Inc. | 2026-10-23 |
| 09120125220242 | Shark Screw® driver cut | surgebright GmbH | 2026-10-22 |
| 00199150080397 | Medtronic Reusable Instruments | MEDTRONIC SOFAMOR DANEK, INC. | 2026-10-19 |
| 00199150080380 | Medtronic Reusable Instruments | MEDTRONIC SOFAMOR DANEK, INC. | 2026-10-19 |
| 00199150080373 | Medtronic Reusable Instruments | MEDTRONIC SOFAMOR DANEK, INC. | 2026-10-19 |
| 00199150076451 | Medtronic Reusable Instruments | MEDTRONIC SOFAMOR DANEK, INC. | 2026-10-19 |
| 00824846013600 | Medtronic Reusable Instruments | MEDTRONIC SOFAMOR DANEK, INC. | 2026-10-19 |
| 00889024709164 | CANNULATED 1.5MM HEX DRIVER | Zimmer, Inc. | 2026-10-19 |
| 00840311245741 | Streamline® MIS Spinal Fixation System | Xtant Medical Holdings, Inc. | 2026-03-18 |
| 00840311245963 | Streamline® MIS Spinal Fixation System | Xtant Medical Holdings, Inc. | 2026-03-18 |
| 00840311245956 | Streamline® MIS Spinal Fixation System | Xtant Medical Holdings, Inc. | 2026-03-18 |
| 00840311245642 | Streamline® MIS Spinal Fixation System | Xtant Medical Holdings, Inc. | 2026-03-18 |
| 00810112597493 | TriLEAP | Synthes GmbH | 2026-02-10 |
| 00810112599756 | TriLEAP | Synthes GmbH | 2026-02-10 |
| 00810112592825 | TriLEAP | Synthes GmbH | 2024-02-23 |
| 00810112592818 | TriLEAP | Synthes GmbH | 2024-02-23 |
| 00810112592627 | TriLEAP | Synthes GmbH | 2024-02-23 |
| 00810028391666 | Arsenal Ankle | Trilliant Surgical, LLC | 2022-05-02 |
| 00888118041791 | LEVEL ONE | KLS-Martin L.P. | 2018-09-26 |