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 |
|---|---|---|---|
| M697X06402401 | Xpress Minimally Invasive Pedicle Screw System | Xtant Medical Holdings, Inc. | 2026-10-14 |
| B382SD1455810020 | Surgical Direct | Surgical Direct, Inc. | 2026-09-29 |
| B382SD1455810030 | Surgical Direct | Surgical Direct, Inc. | 2026-09-29 |
| 10886982345462 | VOLT | Synthes GmbH | 2026-09-25 |
| 00840606197342 | Omega | SPINAL ELEMENTS, INC. | 2026-09-22 |
| 00810112599756 | TriLeap Lower Extremity Anatomic Plating System | CROSSROADS EXTREMITY SYSTEMS | 2026-02-10 |
| 00810112597493 | TriLeap Lower Extremity Anatomic Plating System | CROSSROADS EXTREMITY SYSTEMS | 2026-02-10 |
| 00810112592825 | TriLeap Lower Extremity Anatomic Plating System | CROSSROADS EXTREMITY SYSTEMS | 2024-02-23 |
| 00810112592818 | TriLeap Lower Extremity Anatomic Plating System | CROSSROADS EXTREMITY SYSTEMS | 2024-02-23 |
| 00810112592627 | TriLeap Lower Extremity Anatomic Plating System | CROSSROADS EXTREMITY SYSTEMS | 2024-02-23 |
| 00885556819357 | General Instruments | Smith & Nephew, Inc. | 2023-10-27 |
| 00885556847305 | Tibiaxys Ankle Fusion Plating System | Smith & Nephew, Inc. | 2023-10-13 |
| 00885556847275 | HALLU-Lock M.T.P. Arthrodesis System | Smith & Nephew, Inc. | 2023-10-11 |
| 00885556847268 | TIBIAXYS Ankle Fusion Plating System | Smith & Nephew, Inc. | 2023-10-11 |
| 00885556845707 | GENERAL INSTRUMENTS | Smith & Nephew, Inc. | 2023-10-11 |
| 00885556839935 | Total Foot System 2 | Smith & Nephew, Inc. | 2023-02-02 |
| 00885556835395 | Ti6 Internal Fixation System | Smith & Nephew, Inc. | 2023-02-02 |
| 00885556835388 | Ti6 Internal Fixation System | Smith & Nephew, Inc. | 2023-02-02 |
| 00885556835371 | Ti6 Internal Fixation System | Smith & Nephew, Inc. | 2023-02-02 |
| 00885556835364 | Ti6 Internal Fixation System | Smith & Nephew, Inc. | 2023-02-02 |
| 08055727370785 | FLEX. CARDANIC SCREWDRIVER COATED HEX. 3,5 mm CONN. ZIMMER | HPF SRL | 2022-09-08 |
| B562CDRASS200 | WishBox | Wishbone Medical, Inc. | 2021-06-30 |
| B562HDRASS150 | WishBone K - Wire System | Wishbone Medical, Inc. | 2021-06-30 |
| B562CDRASS150 | WishBox | Wishbone Medical, Inc. | 2021-06-30 |
| B562HDRASS15US0 | WishBone K - Wire System | Wishbone Medical, Inc. | 2021-06-30 |
| B562SDRASS150 | WishBox | Wishbone Medical, Inc. | 2021-06-30 |
| B562SDRASS200 | WishBox | Wishbone Medical, Inc. | 2021-06-30 |
| 00840096400885 | Viant Medical, LLC | VIANT MEDICAL | 2020-05-29 |
| 00840314246349 | gSource | GSOURCE LLC | 2020-03-03 |
| 00840314246295 | gSource | GSOURCE LLC | 2020-03-03 |