K241769
- 510(k) number
- K241769
- Device name
- Response Ortho Metaphyseal Hinge Fixator System
- Applicant
- Response Ortho Solutions, LLC FL · US
- Product code
- KTT — Appliance, Fixation, Nail/Blade/Plate Combination, M
- Decision date
- 2024-09-18
- Date received
- 2024-06-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K241769.pdf
Official FDA record: K241769
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.