MAGEC SPINAL BRACING AND DISTRACTION SYSTEM— 510(k) K140613

Substantially Equivalent

Ellipse Technologies, Inc.

FDA 510(k) clearance K140613 for MAGEC SPINAL BRACING AND DISTRACTION SYSTEM, Substantially Equivalent on 2014-09-18. Applicant: Ellipse Technologies, Inc..

Clearance details

Applicant: Ellipse Technologies, Inc.
Product code: Code PGN
Advisory panel: Orthopedic
Date received: 2014-03-10
Decision date: 2014-09-18
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.