K261121
- 510(k) number
- K261121
- Device name
- Megalodon Dynamic Compression System
- Applicant
- Paragon 28, Inc. CO · US
- Product code
- JDR — Staple, Fixation, Bone
- Decision date
- 2026-08-06
- Date received
- 2026-04-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K261121.pdf
Official FDA record: K261121
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.