K262047
- 510(k) number
- K262047
- Device name
- Grappler Suture Anchor System
- Applicant
- Paragon 28, Inc. CO · US
- Product code
- MBI — Fastener, Fixation, Nondegradable, Soft Tissue
- Decision date
- 2026-08-03
- Date received
- 2026-06-18
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K262047.pdf
Official FDA record: K262047
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.