K252019
- 510(k) number
- K252019
- Device name
- CurvaFix Low Profile System
- Applicant
- Curvafix, Inc. WA · US
- Product code
- HWC — Screw, Fixation, Bone
- Decision date
- 2025-08-29
- Date received
- 2025-06-30
- 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: K252019.pdf
Official FDA record: K252019
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.