K233258
- 510(k) number
- K233258
- Device name
- Shadow Knotless All-Suture Anchors
- Applicant
- Responsive Arthroscopy, LLC MN · US
- Product code
- MBI — Fastener, Fixation, Nondegradable, Soft Tissue
- Decision date
- 2023-10-23
- Date received
- 2023-09-28
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K233258.pdf
Official FDA record: K233258
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.