Cleared Special

TiLink-P SI Joint Fusion System

K240720 · SurGenTec, LLC · Orthopedic
Apr 2024
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K240720 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 April 11, 2024, 27 days after receiving the submission on March 15, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K240720 FDA.gov
FDA Decision Cleared SESE
Date Received March 15, 2024
Decision Date April 11, 2024
Days to Decision 27 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