K242477
- 510(k) number
- K242477
- Device name
- Shoulder Soft Tissue Anchors
- Applicant
- Signature Orthopaedics Pty, Ltd. AU
- Product code
- MBI — Fastener, Fixation, Nondegradable, Soft Tissue
- Decision date
- 2025-05-12
- Date received
- 2024-08-21
- 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: K242477.pdf
Official FDA record: K242477
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.