Cleared Traditional

TiLink-P Joint Fusion System

K242414 · SurGenTec, LLC · Orthopedic
Nov 2024
Decision
99d
Days
Class 2
Risk

About This 510(k) Submission

K242414 is an FDA 510(k) clearance for the TiLink-P 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 November 21, 2024, 99 days after receiving the submission on August 14, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K242414 FDA.gov
FDA Decision Cleared SESE
Date Received August 14, 2024
Decision Date November 21, 2024
Days to Decision 99 days
Submission Type Traditional
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