K243665

Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System (Thread-Fix Ultra Anchor); Crius PEEK Suture Anchor System (Helicoil Anchor); Crius PEEK Suture Anchor System (Pile Anchor)

510(k) number: K243665
Device name: Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System (Thread-Fix Ultra Anchor); Crius PEEK Suture Anchor System (Helicoil Anchor); Crius PEEK Suture Anchor System (Pile Anchor)
Applicant: ZheJiang Decans Medical Devices Co., Ltd. CN
Product code: MBI — Fastener, Fixation, Nondegradable, Soft Tissue
Decision date: 2025-01-31
Date received: 2024-11-27
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: Orthopedic

PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain

Also available from FDA: K243665.pdf

Official FDA record: K243665

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.