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 |
|---|---|---|---|
| B8034709510 | ORTHOMED | ORTHO-MED, INC. | 2026-07-14 |
| B8034803620 | ORTHOMED | ORTHO-MED, INC. | 2026-07-14 |
| B8034803600 | ORTHOMED | ORTHO-MED, INC. | 2026-07-14 |
| B8034803580 | ORTHOMED | ORTHO-MED, INC. | 2026-07-14 |
| B8034803560 | ORTHOMED | ORTHO-MED, INC. | 2026-07-14 |
| B8034803550 | ORTHOMED | ORTHO-MED, INC. | 2026-07-14 |
| B8034803540 | ORTHOMED | ORTHO-MED, INC. | 2026-07-14 |
| B8034803530 | ORTHOMED | ORTHO-MED, INC. | 2026-07-14 |
| B8034803520 | ORTHOMED | ORTHO-MED, INC. | 2026-07-14 |
| B8034803490 | ORTHOMED | ORTHO-MED, INC. | 2026-07-14 |
| B8034803480 | ORTHOMED | ORTHO-MED, INC. | 2026-07-14 |
| B8034709610 | ORTHOMED | ORTHO-MED, INC. | 2026-07-14 |
| B8034709580 | ORTHOMED | ORTHO-MED, INC. | 2026-07-14 |
| B8034709560 | ORTHOMED | ORTHO-MED, INC. | 2026-07-14 |
| B8034709540 | ORTHOMED | ORTHO-MED, INC. | 2026-07-14 |
| B8034709530 | ORTHOMED | ORTHO-MED, INC. | 2026-07-14 |
| B8034500040 | ORTHOMED | ORTHO-MED, INC. | 2026-07-14 |
| B8034803500 | ORTHOMED | ORTHO-MED, INC. | 2026-07-14 |
| 00196449017379 | A.L.P.S. mvX™ | Tyber Medical, LLC | 2026-06-04 |
| 00196449017553 | A.L.P.S. mvX™ | Tyber Medical, LLC | 2026-06-04 |
| 00196449017454 | A.L.P.S. mvX™ | Tyber Medical, LLC | 2026-06-04 |
| 00196449017393 | A.L.P.S. mvX™ | Tyber Medical, LLC | 2026-06-04 |
| 00196449017386 | A.L.P.S. mvX™ | Tyber Medical, LLC | 2026-06-04 |
| 00196449017348 | A.L.P.S. mvX™ | Tyber Medical, LLC | 2026-06-04 |
| 00841731137951 | TITANEX | VILEX LLC | 2026-05-15 |
| 00841731137968 | TITANEX | VILEX LLC | 2026-05-15 |
| 00196449023363 | VOLT™ Wrist Treatment System | Tyber Medical, LLC | 2025-10-21 |
| 10840199515698 | Hex Screw Driver | KOROS U.S.A., INC. | 2024-12-31 |
| 10840199515964 | Screwdriver | KOROS U.S.A., INC. | 2024-12-31 |
| M384K248500 | Bioplate® | Bioplate, Inc. | 2018-10-22 |