Product code LRZ
- Device name
- Screwdriver, Surgical
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4800
- Review panel
- SU
- 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#
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00841731152237 | DYNEX | VILEX LLC | 2026-05-15 |
| 00841731137951 | TITANEX | VILEX LLC | 2026-05-15 |
| 00841731137968 | TITANEX | VILEX LLC | 2026-05-15 |
| 00841731138149 | TITANEX | VILEX LLC | 2026-05-15 |
| 00841731140784 | TITANEX | VILEX LLC | 2026-05-15 |
| 00841731141927 | TITANEX | VILEX LLC | 2026-05-15 |
| 00841731146816 | TITANEX | VILEX LLC | 2026-05-15 |
| 00841731146823 | TITANEX | VILEX LLC | 2026-05-15 |
| 00841731146830 | TITANEX | VILEX LLC | 2026-05-15 |
| 00841731146847 | TITANEX | VILEX LLC | 2026-05-15 |
| 00841731152282 | DYNEX | VILEX LLC | 2026-05-11 |
| 00841731152183 | DYNEX | VILEX LLC | 2026-05-11 |
| 00841731152121 | DYNEX | VILEX LLC | 2026-05-11 |
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| 08800016114485 | Dental Instrument | Cowellmedi Co.,Ltd | 2026-01-28 |
| 08800016163087 | Dental Instrument | Cowellmedi Co.,Ltd | 2026-01-28 |
| 08800016114478 | Dental Instrument | Cowellmedi Co.,Ltd | 2026-01-28 |
| 08800016115840 | Dental Instrument | Cowellmedi Co.,Ltd | 2026-01-28 |
| 08800016115857 | Dental Instrument | Cowellmedi Co.,Ltd | 2026-01-28 |
| 08800016116014 | Dental Instrument | Cowellmedi Co.,Ltd | 2026-01-28 |
| 08800016144772 | Dental Instrument | Cowellmedi Co.,Ltd | 2026-01-28 |
| 08800016114461 | Dental Instrument | Cowellmedi Co.,Ltd | 2026-01-28 |
| 08800016114454 | Dental Instrument | Cowellmedi Co.,Ltd | 2026-01-28 |
| 08800016114447 | Dental Instrument | Cowellmedi Co.,Ltd | 2026-01-28 |
| 08800016101362 | Dental Instrument | Cowellmedi Co.,Ltd | 2026-01-28 |
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| M384K248500 | BioplateĀ® | Bioplate, Inc. | 2018-10-22 |