3° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity Lumbosacral Fixation System, Hallmark Anterior Plate System, NewBridge Laminoplasty Fixation System, CETRA Anterior Cervical Plate System— 510(k) K211712

Name: FDA 510(k) clearance K211712
Creator: U.S. Food and Drug Administration
Published: 2022-02-11

Substantially Equivalent

Orthofix US, LLC

FDA 510(k) clearance K211712 for 3° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity Lumbosacral Fixation System, Hallmark Anterior Plate System, NewBridge Laminoplasty Fixation System, CETRA Anterior Cervical Plate System, Substantially Equivalent on 2022-02-11. Applicant: Orthofix US, LLC. Device class: 2.

Clearance details

Applicant: Orthofix US, LLC
Product code: Code KWQ
Device class: Class 2
Regulation: 21 CFR 888.3060
Advisory panel: Orthopedic
Date received: 2021-06-03
Decision date: 2022-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lewisville, TX, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KWQ

product code KWQ

Death: 8
Injury: 1,212
Malfunction: 1,233
Total: 2,453

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.