K242307
- 510(k) number
- K242307
- Device name
- ACHIEVE Partial Knee System
- Applicant
- Ignite Orthomotion IN · US
- Product code
- NJD — Prosthesis, Knee, Femorotibial, Unicompartmental/Uni
- Decision date
- 2024-12-16
- Date received
- 2024-08-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K242307.pdf
Official FDA record: K242307
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.