K253027
- 510(k) number
- K253027
- Device name
- Anchor with Fiber Wire and Disposable Inserter
- Applicant
- Ortobio S.A. BR
- Product code
- MBI — Fastener, Fixation, Nondegradable, Soft Tissue
- Decision date
- 2026-05-06
- Date received
- 2025-09-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K253027.pdf
Official FDA record: K253027
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.