MAGEC 2 Spinal Bracing and Distraction System— 510(k) K150885

Substantially Equivalent

Ellipse Technologies, Incorporated

FDA 510(k) clearance K150885 for MAGEC 2 Spinal Bracing and Distraction System, Substantially Equivalent on 2015-05-29. Applicant: Ellipse Technologies, Incorporated.

Clearance details

Applicant: Ellipse Technologies, Incorporated
Product code: Code PGN
Advisory panel: Orthopedic
Date received: 2015-04-02
Decision date: 2015-05-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

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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.