Cleared Special

TiLink-P SI Joint Fusion System

K243835 · SurGenTec, LLC · Orthopedic
Dec 2024
Decision
14d
Days
Class 2
Risk

About This 510(k) Submission

K243835 is an FDA 510(k) clearance for the TiLink-P SI Joint Fusion System, a Sacroiliac Joint Fixation (Class II — Special Controls, product code OUR), submitted by SurGenTec, LLC (Boca Raton, US). The FDA issued a Cleared decision on December 27, 2024, 14 days after receiving the submission on December 13, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K243835 FDA.gov
FDA Decision Cleared SESE
Date Received December 13, 2024
Decision Date December 27, 2024
Days to Decision 14 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code OUR — Sacroiliac Joint Fixation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040
Definition Sacroiliac Joint Fusion