K232513
- 510(k) number
- K232513
- Device name
- X-Twist Biocomposite Suture Anchor
- Applicant
- Parcus Medical FL · US
- Product code
- MAI — Fastener, Fixation, Biodegradable, Soft Tissue
- Decision date
- 2023-09-18
- Date received
- 2023-08-18
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K232513.pdf
Official FDA record: K232513
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.