Cleared Traditional

K233593 - MAGEC Spinal Bracing and Distraction System

K233593 is an FDA 510(k) clearance for MAGEC Spinal Bracing and Distraction System, manufactured by Nuvasive Specialized Orthopedics, Incorporated. The device is a Class 2 Orthopedic device with product code PGN cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K233593 · Nuvasive Specialized Orthopedics, Incorporated · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2024
Decision
90d
Days
Class 2
Risk

K233593 is an FDA 510(k) clearance for the MAGEC Spinal Bracing and Distraction System. Classified as Growing Rod System- Magnetic Actuation (product code PGN), Class II - Special Controls.

Submitted by Nuvasive Specialized Orthopedics, Incorporated (Alisa Viejo, US). The FDA issued a Cleared decision on February 6, 2024 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Nuvasive Specialized Orthopedics, Incorporated devices

FDA 510(k) Submission Details - K233593

510(k) Number K233593 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2023
Decision Date February 06, 2024
Days to Decision 90 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PGN Device Classification - Class 2, Special Controls

Product Code PGN Growing Rod System- Magnetic Actuation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
Definition Stabilization Or Correction Of Spinal Deformities Without The Use Of Fusion, Using Non-invasive Methods To Adjust The Spinal Rod.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.