K242296
- 510(k) number
- K242296
- Device name
- VersaTap Suture Anchor (ADP050); VersaPEEK Suture Anchor (APP002); MicroTi Suture Anchor (ATP003-M); VersaLat Ti Suture Anchor (ADP021-TI); VersaLat Suture Anchor (ADP021-PK)
- Applicant
- Ortho-Design (Pty), Ltd. ZA
- Product code
- MBI — Fastener, Fixation, Nondegradable, Soft Tissue
- Decision date
- 2024-08-29
- Date received
- 2024-08-02
- 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: K242296.pdf
Official FDA record: K242296
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.