Cleared Traditional

TiLink-P SI Joint Fusion System

K230857 · SurGenTec, LLC · Orthopedic
Sep 2023
Decision
180d
Days
Class 2
Risk

About This 510(k) Submission

K230857 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 September 25, 2023, 180 days after receiving the submission on March 29, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K230857 FDA.gov
FDA Decision Cleared SESE
Date Received March 29, 2023
Decision Date September 25, 2023
Days to Decision 180 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