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 |
|---|---|---|---|
| 07640139343185 | BAGUERA C INSTRUMENTATION | SpineArt SA | 2026-08-27 |
| 00843210143644 | Monaco Pedicle Screw System | Altus Spine, LLC | 2026-08-24 |
| 00199150083091 | Medtronic Reusable Instruments | MEDTRONIC SOFAMOR DANEK, INC. | 2026-08-22 |
| B095329646 | Hintermann Series | Dt Medtech, LLC | 2026-08-21 |
| 00199150083466 | Medtronic Reusable Instruments | MEDTRONIC SOFAMOR DANEK, INC. | 2026-08-08 |
| 00199150083459 | Medtronic Reusable Instruments | MEDTRONIC SOFAMOR DANEK, INC. | 2026-08-08 |
| 00199150076468 | Medtronic Reusable Instruments | MEDTRONIC SOFAMOR DANEK, INC. | 2026-08-03 |
| 00199150076475 | Medtronic Reusable Instruments | MEDTRONIC SOFAMOR DANEK, INC. | 2026-08-03 |
| 00840606191951 | Overwatch PCF | SPINAL ELEMENTS, INC. | 2026-07-31 |
| 00840606191944 | Overwatch PCF | SPINAL ELEMENTS, INC. | 2026-07-31 |
| 00840606191982 | Overwatch PCF | SPINAL ELEMENTS, INC. | 2026-07-31 |
| 00840606191784 | Overwatch PCF | SPINAL ELEMENTS, INC. | 2026-07-31 |
| 00840606191753 | Overwatch PCF | SPINAL ELEMENTS, INC. | 2026-07-31 |
| 00840606191746 | Overwatch PCF | SPINAL ELEMENTS, INC. | 2026-07-31 |
| 00840606191623 | Overwatch PCF | SPINAL ELEMENTS, INC. | 2026-07-31 |
| 00840606191616 | Overwatch PCF | SPINAL ELEMENTS, INC. | 2026-07-31 |
| 03701089540643 | AMPLITUDE | AMPLITUDE SAS | 2026-07-29 |
| 03701089541022 | AMPLITUDE | AMPLITUDE SAS | 2026-07-29 |
| 00613994907431 | Medtronic Reusable Instruments | MEDTRONIC SOFAMOR DANEK, INC. | 2022-10-10 |
| 00643169191440 | Medtronic Reusable Instruments | MEDTRONIC SOFAMOR DANEK, INC. | 2022-10-08 |
| 10885862085726 | Equinoxe | Exactech, Inc. | 2022-07-28 |
| B56251201200T15G10 | WishBone | Wishbone Medical, Inc. | 2022-07-18 |
| B56251201200T15G00 | WishBone | Wishbone Medical, Inc. | 2022-07-18 |
| B562SDRASS200 | WishBox | Wishbone Medical, Inc. | 2021-06-30 |
| B562SDRASS150 | WishBox | Wishbone Medical, Inc. | 2021-06-30 |
| B562CDRASS200 | WishBox | Wishbone Medical, Inc. | 2021-06-30 |
| B562CDRASS150 | WishBox | Wishbone Medical, Inc. | 2021-06-30 |
| B095319645 | Hintermann Series | Dt Medtech, LLC | 2018-10-03 |
| 10886982000941 | NA | Synthes GmbH | 2017-02-20 |
| 10886982000934 | NA | Synthes GmbH | 2017-02-20 |