K232725
- 510(k) number
- K232725
- Device name
- Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor
- Applicant
- Suzhou Endophix Co., Ltd. CN
- Product code
- MBI — Fastener, Fixation, Nondegradable, Soft Tissue
- Decision date
- 2023-11-02
- Date received
- 2023-09-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K232725.pdf
Official FDA record: K232725
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.