510(k) K243461
- Device
- Calibrate Interbody Systems
- Applicant
- Alphatec Spine, Inc.
- 510(k) number
- K243461
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-03-04
- Date received
- 2024-11-08
- Review panel
- Unknown
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Andrew Zhang
- Address
- 1950 Camino Vida Roble Carlsbad CA US 92008 92008
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00190376664552 | Calibrate | ALPHATEC SPINE, INC. | 2025-05-30 |
| 00190376664613 | Calibrate | ALPHATEC SPINE, INC. | 2025-05-30 |
| 00190376664453 | Calibrate | ALPHATEC SPINE, INC. | 2025-05-30 |
| 00190376664378 | Calibrate | ALPHATEC SPINE, INC. | 2025-05-30 |
| 00190376664330 | Calibrate | ALPHATEC SPINE, INC. | 2025-05-30 |
| 00190376603940 | Calibrate | ALPHATEC SPINE, INC. | 2025-05-30 |
| 00190376664361 | Calibrate | ALPHATEC SPINE, INC. | 2025-05-30 |
| 00190376664446 | Calibrate | ALPHATEC SPINE, INC. | 2025-05-30 |
| 00190376664408 | Calibrate | ALPHATEC SPINE, INC. | 2025-05-30 |
| 00190376664385 | Calibrate | ALPHATEC SPINE, INC. | 2025-05-30 |
| 00190376664606 | Calibrate | ALPHATEC SPINE, INC. | 2025-05-30 |
| 00190376664521 | Calibrate | ALPHATEC SPINE, INC. | 2025-05-30 |
| 00190376664484 | Calibrate | ALPHATEC SPINE, INC. | 2025-05-30 |
| 00190376664460 | Calibrate | ALPHATEC SPINE, INC. | 2025-05-30 |
| 00190376664514 | Calibrate | ALPHATEC SPINE, INC. | 2025-05-30 |
| 00190376664590 | Calibrate | ALPHATEC SPINE, INC. | 2025-05-30 |
| 00190376664576 | Calibrate | ALPHATEC SPINE, INC. | 2025-05-30 |
| 00190376664538 | Calibrate | ALPHATEC SPINE, INC. | 2025-05-30 |
| 00190376664439 | Calibrate | ALPHATEC SPINE, INC. | 2025-05-30 |
| 00190376664347 | Calibrate | ALPHATEC SPINE, INC. | 2025-05-30 |
| 00190376664323 | Calibrate | ALPHATEC SPINE, INC. | 2025-05-30 |
| 00190376664415 | Calibrate | ALPHATEC SPINE, INC. | 2025-05-30 |
| 00190376664583 | Calibrate | ALPHATEC SPINE, INC. | 2025-05-30 |
| 00190376664491 | Calibrate | ALPHATEC SPINE, INC. | 2025-05-30 |
| 00190376664477 | Calibrate | ALPHATEC SPINE, INC. | 2025-05-30 |
| 00190376664569 | Calibrate | ALPHATEC SPINE, INC. | 2025-05-30 |
| 00190376664392 | Calibrate | ALPHATEC SPINE, INC. | 2025-05-30 |
| 00190376664354 | Calibrate | ALPHATEC SPINE, INC. | 2025-05-30 |
| 00190376664545 | Calibrate | ALPHATEC SPINE, INC. | 2025-05-30 |
| 00190376664507 | Calibrate | ALPHATEC SPINE, INC. | 2025-05-30 |