K262722
- 510(k) number
- K262722
- Device name
- Primal K-Wire (P99-193-1410)
- Applicant
- Paragon 28, Inc. CO · US
- Product code
- HTY — Pin, Fixation, Smooth
- Decision date
- 2026-08-28
- Date received
- 2026-07-31
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K262722.pdf
Official FDA record: K262722
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.