OSTAPEK VBR SYSTEM— 510(k) K072326

Name: FDA 510(k) clearance K072326
Creator: U.S. Food and Drug Administration
Published: 2008-06-24

Substantially Equivalent

Co-Ligne AG

FDA 510(k) clearance K072326 for OSTAPEK VBR SYSTEM, Substantially Equivalent on 2008-06-24. Applicant: Co-Ligne AG. Device class: 2.

Clearance details

Applicant: Co-Ligne AG
Product code: Code MQP
Device class: Class 2
Regulation: 21 CFR 888.3060
Advisory panel: Orthopedic
Date received: 2007-08-20
Decision date: 2008-06-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Concord, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MQP

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K253158 — VyBrate VBR System2026-01-07
K241468 — Vertiwedge® Intraosseous System2024-11-07
K232790 — KONG®-TL VBR System and KONG® C VBR System2024-04-04

More clearances from Co-Ligne AG

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K083567 — GII SPINAL FIXATION SYSTEM, GII-TI-POLY AXIAL SCREW2009-09-14
K051089 — GII SPINAL FIXATION SYSTEM2005-10-26
K032604 — GII SPINAL FIXATION SYSTEM2004-01-20

Adverse events under product code MQP

product code MQP

Injury: 372
Malfunction: 519
Total: 891

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.