K232586
- 510(k) number
- K232586
- Device name
- Rexious Spinal Fixation System, Statera Spinal System, Statera-M Spinal System
- Applicant
- K&J Consulting Corp. PA · US
- Product code
- NKB — Thoracolumbosacral Pedicle Screw System
- Decision date
- 2023-10-24
- Date received
- 2023-08-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K232586.pdf
Official FDA record: K232586
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.