K240180
- 510(k) number
- K240180
- Device name
- Orthopeasia Spinal Fixation System
- Applicant
- Orthopeasia Co., Ltd. TH
- Product code
- NKB — Thoracolumbosacral Pedicle Screw System
- Decision date
- 2024-08-30
- Date received
- 2024-01-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K240180.pdf
Official FDA record: K240180
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.