K250769
- 510(k) number
- K250769
- Device name
- Dakota LP System
- Applicant
- Precision Spine, Inc. MS · US
- Product code
- ODP — Intervertebral Fusion Device With Bone Graft, Cervic
- Decision date
- 2025-11-24
- Date received
- 2025-03-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.4 MB · U.S. public domain
Also available from FDA: K250769.pdf
Official FDA record: K250769
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.