K243477
- 510(k) number
- K243477
- Device name
- Universal Tendon Spacer
- Applicant
- Askorn Medical FR
- Product code
- HXA — Prosthesis, Tendon, Passive
- Decision date
- 2025-01-10
- Date received
- 2024-11-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 2.1 MB · U.S. public domain
Also available from FDA: K243477.pdf
Official FDA record: K243477
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.