K232719
- 510(k) number
- K232719
- Device name
- ProMIS Extension Rod System
- Applicant
- Premia Spine, Ltd. IL
- Product code
- NKB — Thoracolumbosacral Pedicle Screw System
- Decision date
- 2023-11-21
- Date received
- 2023-09-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K232719.pdf
Official FDA record: K232719
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.