K250952
- 510(k) number
- K250952
- Device name
- Baby Gorilla®/Gorilla® Plating System
- Applicant
- Paragon 28, Inc. CO · US
- Product code
- HRS — Plate, Fixation, Bone
- Decision date
- 2025-07-18
- Date received
- 2025-03-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K250952.pdf
Official FDA record: K250952
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.