K243461 is an FDA 510(k) clearance for the Calibrate Interbody Systems..
Submitted by Alphatec Spine, Inc. (Carlsbad, US). The FDA issued a Cleared decision on March 4, 2025, 116 days after receiving the submission on November 8, 2024.
This device falls under the Orthopedic FDA review panel.
| 510(k) Number | K243461 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 08, 2024 |
| Decision Date | March 04, 2025 |
| Days to Decision | 116 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | — |
| Device Class | — |