K241262
- 510(k) number
- K241262
- Device name
- Baby Gorilla/Gorilla Plating System; Monster Screw System
- Applicant
- Paragon 28, Inc. CO · US
- Product code
- HRS — Plate, Fixation, Bone
- Decision date
- 2024-06-05
- Date received
- 2024-05-06
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 3.2 MB · U.S. public domain
Also available from FDA: K241262.pdf
Official FDA record: K241262
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.