K233105
- 510(k) number
- K233105
- Device name
- RESPONSE Rib and Pelvic System
- Applicant
- OrthoPediatrics Corp. IN · US
- Product code
- MDI — Prosthesis, Rib Replacement
- Decision date
- 2024-01-20
- Date received
- 2023-09-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K233105.pdf
Official FDA record: K233105
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.