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 |
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|---|---|---|---|
| 07640221373076 | PERLA ® TL | SpineArt SA | 2026-05-07 |
| 07640332475300 | PERLA ® | SpineArt SA | 2025-11-10 |
| 07640332475294 | PERLA ® | SpineArt SA | 2025-11-10 |
| 00841732142312 | GENERIC Surgical Instruments | CTL Medical Corporation | 2025-03-31 |
| 00841732160347 | GENERIC Surgical Instruments | CTL Medical Corporation | 2025-03-31 |
| 00841732145078 | GENERIC Surgical Instruments | CTL Medical Corporation | 2025-03-31 |
| 00841732143074 | GENERIC Surgical Instruments | CTL Medical Corporation | 2025-03-31 |
| 00841732142466 | GENERIC Surgical Instruments | CTL Medical Corporation | 2025-03-31 |
| 00841732142459 | GENERIC Surgical Instruments | CTL Medical Corporation | 2025-03-31 |
| 00841732142442 | GENERIC Surgical Instruments | CTL Medical Corporation | 2025-03-31 |
| 00841732142473 | GENERIC Surgical Instruments | CTL Medical Corporation | 2025-03-31 |
| 00841732142428 | GENERIC Surgical Instruments | CTL Medical Corporation | 2025-03-31 |
| 00841732142435 | GENERIC Surgical Instruments | CTL Medical Corporation | 2025-03-31 |
| 00841732142190 | GENERIC Surgical Instruments | CTL Medical Corporation | 2025-03-28 |
| 00841732166738 | GENERIC Surgical Instruments | CTL Medical Corporation | 2024-12-04 |
| 00841732166721 | GENERIC Surgical Instruments | CTL Medical Corporation | 2024-12-04 |
| 00810118210259 | .050 Driver, Short | Osteocentric Technologies, Inc. | 2023-10-31 |
| 00810118210266 | .050 Driver, Long | Osteocentric Technologies, Inc. | 2023-10-31 |
| 00810118210273 | .050 Driver, Latch | Osteocentric Technologies, Inc. | 2023-10-31 |
| 00810118210280 | Thumb Knob | Osteocentric Technologies, Inc. | 2023-10-31 |
| 00810118210327 | Latch Driver, 300 Series | Osteocentric Technologies, Inc. | 2023-10-31 |
| 00810118210334 | Square Driver, 300 Series | Osteocentric Technologies, Inc. | 2023-10-31 |
| 00810118210341 | Latch Driver, 400 Series | Osteocentric Technologies, Inc. | 2023-10-31 |
| 00810118210358 | Square Driver, 400 Series | Osteocentric Technologies, Inc. | 2023-10-31 |
| 00810118210365 | Ratchet Adapter | Osteocentric Technologies, Inc. | 2023-10-31 |
| 00810118210198 | Torque Wrench | Osteocentric Technologies, Inc. | 2023-10-31 |
| 07640177820440 | Neo Medical Pedicle Screw System | Neo Medical SA | 2023-01-26 |
| 07640187460582 | Screwdriver 2.5mm | Bonebridge AG | 2022-12-23 |
| 07640185341050 | TRYPTIK 2 C-PLATE INSTRUMENTATION | SpineArt SA | 2019-02-12 |
| 07640178985568 | ROMEO 2 INSTRUMENTATION | SpineArt SA | 2019-02-01 |