K250769 is an FDA 510(k) clearance for the Dakota LP System. This device is classified as a Intervertebral Fusion Device With Bone Graft, Cervical (Class II - Special Controls, product code ODP).
Submitted by Precision Spine, Inc. (Pear, US). The FDA issued a Cleared decision on November 24, 2025, 256 days after receiving the submission on March 13, 2025.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3080. Intended To Stabilize Cervical Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft..
| 510(k) Number | K250769 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 13, 2025 |
| Decision Date | November 24, 2025 |
| Days to Decision | 256 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | ODP — Intervertebral Fusion Device With Bone Graft, Cervical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3080 |
| Definition | Intended To Stabilize Cervical Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft. |