K241258
- 510(k) number
- K241258
- Device name
- Ingenix Spinal System
- Applicant
- Ingenium Spine AZ · US
- Product code
- NKB — Thoracolumbosacral Pedicle Screw System
- Decision date
- 2024-06-04
- Date received
- 2024-05-06
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K241258.pdf
Official FDA record: K241258
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.