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FDA 510(k)

MAGEC Spinal Bracing and Distraction System

K-Number: K233593 · 2024-02-06

ApplicantNuvasive Specialized Orthopedics, Incorporated
Decision Date2024-02-06
Product CodePGN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MAGEC Spinal Bracing and Distraction System is a medical device manufactured by Nuvasive Specialized Orthopedics, Incorporated. It received FDA 510(k) clearance on 2024-02-06 under approval number K233593. The device is classified under product code PGN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAGEC Spinal Bracing and Distraction System?

MAGEC Spinal Bracing and Distraction System is a medical device that received FDA 510(k) clearance on 2024-02-06. It is manufactured by Nuvasive Specialized Orthopedics, Incorporated. The 510(k) number is K233593.

When was MAGEC Spinal Bracing and Distraction System approved by the FDA?

MAGEC Spinal Bracing and Distraction System received FDA 510(k) clearance on 2024-02-06, under approval number K233593.

What company makes MAGEC Spinal Bracing and Distraction System?

MAGEC Spinal Bracing and Distraction System is manufactured by Nuvasive Specialized Orthopedics, Incorporated.

What is the FDA product code for MAGEC Spinal Bracing and Distraction System?

The FDA product code for MAGEC Spinal Bracing and Distraction System is PGN.

Related Clinical Trials

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Related PubMed Literature

PMID: 35685299 Multicenter, Double-Blinded, Randomized, Active-Sham Controlled Clinical Study Design to Assess the Safety and Effectiveness of a Novel High Frequency Electric Nerve Block System in the Treatment of Post-Amputation Pain (The QUEST Study). Journal of pain research (2022)

Other Devices by Nuvasive Specialized Orthopedics, Incorporated

K171791MAGEC® System K170939Supplemental Instrument Trays K232267Precice Max System

Related Devices (Code: PGN)

K160352MAGEC® Spinal Bracing and Distraction SystemNuvasive Specialized Orthopedics, Inc. K161751MAGEC® Spinal Bracing and Distraction SystemNuvasive Specialized Orthopedics, Inc. K171791MAGEC® SystemNuvasive Specialized Orthopedics, Incorporated K201543MAGEC® SystemNuvasive Specialized Orthopedics, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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