MAGEC Spinal Bracing and Distraction System— 510(k) K233593

Name: FDA 510(k) clearance K233593
Creator: U.S. Food and Drug Administration
Published: 2024-02-06

Substantially Equivalent

Nuvasive Specialized Orthopedics, Incorporated

FDA 510(k) clearance K233593 for MAGEC Spinal Bracing and Distraction System, Substantially Equivalent on 2024-02-06. Applicant: Nuvasive Specialized Orthopedics, Incorporated. Device class: 2.

Clearance details

Applicant: Nuvasive Specialized Orthopedics, Incorporated
Product code: Code PGN
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2023-11-08
Decision date: 2024-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alisa Viejo, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PGN

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K201543 — MAGEC® System2020-07-30
K171791 — MAGEC® System2017-08-31
K160352 — MAGEC® Spinal Bracing and Distraction System2016-10-21
K161751 — MAGEC® Spinal Bracing and Distraction System2016-09-02
K150885 — MAGEC 2 Spinal Bracing and Distraction System2015-05-29

More clearances from Nuvasive Specialized Orthopedics, Incorporated

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K232267 — Precice Max System2023-12-15
K170939 — Supplemental Instrument Trays2017-08-08

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.