RibPlate System— 510(k) K261054

Name: FDA 510(k) clearance K261054
Creator: U.S. Food and Drug Administration
Published: 2026-07-01

Substantially Equivalent

Stryker Leibinger GmbH & Co KG

FDA 510(k) clearance K261054 for RibPlate System, Substantially Equivalent on 2026-07-01. Applicant: Stryker Leibinger GmbH & Co KG. Device class: 2.

Clearance details

Applicant: Stryker Leibinger GmbH & Co KG
Product code: Code HRS
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2026-03-31
Decision date: 2026-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Freiburg, DE

Download summary PDF View on FDA.gov ↗

Recent devices under product code HRS

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K261830 — FRAXION 3.5 Plate System (Various - See Catalog) +3 more2026-08-28
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K260277 — MIKRON TRAUMA BONE PLATE& SCREW SYSTEM2026-08-13
K261511 — Xpert Ankle2026-07-28
K261406 — Versalock Proximal Tibial Plating System2026-07-21

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K252871 — Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories2026-02-06
K243491 — SternalPlate Expansion2024-12-11
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Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.