Airlock Centrolock Osteosynthesis Implant System— 510(k) K192356

Name: FDA 510(k) clearance K192356
Creator: U.S. Food and Drug Administration
Published: 2019-12-14

Substantially Equivalent

Novastep

FDA 510(k) clearance K192356 for Airlock Centrolock Osteosynthesis Implant System, Substantially Equivalent on 2019-12-14. Applicant: Novastep. Device class: 2.

Clearance details

Applicant: Novastep
Product code: Code HRS
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2019-08-29
Decision date: 2019-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Saint-Gregoire, FR

Download summary PDF View on FDA.gov ↗

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K143523 — Airlock osteosynthesis plate system2015-04-06
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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.