K231231
- 510(k) number
- K231231
- Device name
- MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation Devices
- Applicant
- Paragon 28, Inc. CO · US
- Product code
- HWC — Screw, Fixation, Bone
- Decision date
- 2023-10-12
- Date received
- 2023-04-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 2.9 MB · U.S. public domain
Also available from FDA: K231231.pdf
Official FDA record: K231231
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.