K253660
- 510(k) number
- K253660
- Device name
- KLS Martin Pure Pectus System
- Applicant
- KLS-Martin L.P. FL · US
- Product code
- HRS — Plate, Fixation, Bone
- Decision date
- 2026-02-20
- Date received
- 2025-11-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K253660.pdf
Official FDA record: K253660
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.