K254165
- 510(k) number
- K254165
- Device name
- Infinity OCT System
- Applicant
- Medtronic Sofamor Danek USA, Inc. TN · US
- Product code
- NKG — Posterior Cervical Screw System
- Decision date
- 2026-01-21
- Date received
- 2025-12-22
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K254165.pdf
Official FDA record: K254165
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.