K253886
- 510(k) number
- K253886
- Device name
- Grappler Suture Anchor PCFD Tether System
- Applicant
- Paragon 28, Inc. CO · US
- Product code
- MBI — Fastener, Fixation, Nondegradable, Soft Tissue
- Decision date
- 2026-03-17
- Date received
- 2025-12-04
- 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: K253886.pdf
Official FDA record: K253886
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.