K260921
- 510(k) number
- K260921
- Device name
- Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line
- Applicant
- Tigon Medical MD · US
- Product code
- MBI — Fastener, Fixation, Nondegradable, Soft Tissue
- Decision date
- 2026-04-21
- Date received
- 2026-03-19
- 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: K260921.pdf
Official FDA record: K260921
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.