MAGEC® Spinal Bracing and Distraction System— 510(k) K161751

Substantially Equivalent

Nuvasive Specialized Orthopedics, Inc.

FDA 510(k) clearance K161751 for MAGEC® Spinal Bracing and Distraction System, Substantially Equivalent on 2016-09-02. Applicant: Nuvasive Specialized Orthopedics, Inc..

Clearance details

Applicant: Nuvasive Specialized Orthopedics, Inc.
Product code: Code PGN
Advisory panel: Orthopedic
Date received: 2016-06-24
Decision date: 2016-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alisa Viejo, CA, US

Download summary PDF View on FDA.gov ↗

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.