MAGEC SPINAL BRACING AND DISTRACTION SYSTEM— 510(k) K141278

Name: FDA 510(k) clearance K141278
Creator: U.S. Food and Drug Administration
Published: 2015-03-24

Substantially Equivalent

Ellipse Technologies, Inc.

FDA 510(k) clearance K141278 for MAGEC SPINAL BRACING AND DISTRACTION SYSTEM, Substantially Equivalent on 2015-03-24. Applicant: Ellipse Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Ellipse Technologies, Inc.
Product code: Code PGN
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2014-05-16
Decision date: 2015-03-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code PGN

product code PGN

Injury: 253
Malfunction: 633
Total: 886

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.