Cleared Traditional

RIB LINK? Fixation System

K252166 · Globus Medical, Inc. · Orthopedic
Feb 2026
Decision
231d
Days
Class 2
Risk

About This 510(k) Submission

K252166 is an FDA 510(k) clearance for the RIB LINK? Fixation System, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Globus Medical, Inc. (Audubon, US). The FDA issued a Cleared decision on February 26, 2026, 231 days after receiving the submission on July 10, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K252166 FDA.gov
FDA Decision Cleared SESE
Date Received July 10, 2025
Decision Date February 26, 2026
Days to Decision 231 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HRS — Plate, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

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