RIB LINK Fixation System— 510(k) K252166
Substantially EquivalentGlobus Medical, Inc.
FDA 510(k) clearance K252166 for RIB LINK Fixation System, Substantially Equivalent on 2026-02-26. Applicant: Globus Medical, Inc.. Device class: 2.
Summary
Globus Medical's RIB LINK Fixation System is filed under product code HRS, bone fixation plate. The record doesn't list components or models.
Class II, 21 CFR 888.3030. Orthopedic is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Globus Medical filed from Audubon, Pennsylvania. The substantially equivalent decision came 231 calendar days after receipt (July 10, 2025 to February 26, 2026).
Clearance details
- Applicant
- Globus Medical, Inc.
- Product code
- Product code HRS
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Audubon, PA, US
Recent devices under product code HRS
view allMore clearances from Globus Medical, Inc.
view all- K254043 — TRIVANCE Hip Stem
- K262251 — ACTIFY Total Knee System, ACTIFY 3D Total Knee System (ACTIFY MC Tibial Insert)
- K253739 — SCRIPT Rods, CREO Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline System
- K253401 — SCRIPT Implant System
- K261043 — AUTOBAHN Nailing System
Adverse events under product code HRS
product code HRS- Death
- 27
- Injury
- 10,340
- Malfunction
- 3,328
- Total
- 13,695
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.