Product code LYQ
- Device name
- Accessories, Fixation, Spinal Intervertebral Body
- 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#
Related GUDID Devices#
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|---|---|---|---|
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| 00859373004029 | Passer | EMPIRICAL SPINE, INC. | 2026-03-27 |
| 00859373004050 | Driver | EMPIRICAL SPINE, INC. | 2026-03-27 |
| 00859373004067 | Tensioner Clip | EMPIRICAL SPINE, INC. | 2026-03-27 |
| 00859373004074 | Tensioner | EMPIRICAL SPINE, INC. | 2026-03-27 |
| 00840493416441 | LUX Expandable Interbody System | XENIX MEDICAL LLC | 2026-02-23 |
| 00840493416458 | LUX Expandable Interbody System | XENIX MEDICAL LLC | 2026-02-23 |
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| 00818345029606 | RIVA Pedicle Screw System | XENIX MEDICAL LLC | 2025-10-27 |
| 00818345029620 | RIVA Pedicle Screw System | XENIX MEDICAL LLC | 2025-10-27 |
| 00818345029637 | RIVA Pedicle Screw System | XENIX MEDICAL LLC | 2025-10-27 |
| 00818345029644 | RIVA Pedicle Screw System | XENIX MEDICAL LLC | 2025-10-27 |
| G616G1090914DS1 | PTS | Pt. Solutions, LLC | 2025-10-06 |
| G616G1090912DS1 | PTS | Pt. Solutions, LLC | 2025-10-06 |
| G616G190916DS0 | PTS | Pt. Solutions, LLC | 2025-10-06 |
| G616G190914DS0 | PTS | Pt. Solutions, LLC | 2025-10-06 |
| G616G190912DS0 | PTS | Pt. Solutions, LLC | 2025-10-06 |
| G616G1090916DS1 | PTS | Pt. Solutions, LLC | 2025-10-06 |
| 00818614022642 | ABS Med Distraction Pin | MEDLINE INDUSTRIES, INC. | 2023-08-29 |
| 00818614021416 | Distraction Screw | MEDLINE INDUSTRIES, INC. | 2023-01-26 |
| 00818614021409 | Distraction Screw | MEDLINE INDUSTRIES, INC. | 2023-01-26 |
| 00840298700608 | CODA™ Anterior Cervical Plate System | Pioneer Surgical Technology, Inc. | 2023-01-24 |
| 00818614022611 | Distraction Pin, 14MM pouch | MEDLINE INDUSTRIES, INC. | 2022-12-19 |
| 00818614022604 | Distraction Pin, 12MM pouch | MEDLINE INDUSTRIES, INC. | 2022-12-19 |
| 00818614022581 | Distraction Screw, 14MM pouch | MEDLINE INDUSTRIES, INC. | 2022-09-01 |
| 00818614022574 | Distraction Screw, 12MM pouch | MEDLINE INDUSTRIES, INC. | 2022-09-01 |
| 00818614022512 | Distraction Pin , 14MM Pouch | MEDLINE INDUSTRIES, INC. | 2022-05-06 |
| 00818614022505 | Distraction Pin , 12MM Pouch | MEDLINE INDUSTRIES, INC. | 2022-05-06 |