K241657
- 510(k) number
- K241657
- Device name
- MSFX MIKRON SPINAL FIXATION SYSTEM
- Applicant
- Mikron Makina Sanayi VE Ticaret Ltd. Sti. TR
- Product code
- NKB — Thoracolumbosacral Pedicle Screw System
- Decision date
- 2024-09-30
- Date received
- 2024-06-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K241657.pdf
Official FDA record: K241657
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.