K230974
- 510(k) number
- K230974
- Device name
- NIDO Pedicle Screw System
- Applicant
- Kalitec Medical FL · US
- Product code
- NKB — Thoracolumbosacral Pedicle Screw System
- Decision date
- 2023-09-15
- Date received
- 2023-04-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K230974.pdf
Official FDA record: K230974
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.