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FDA 510(k)

MAGEC® Spinal Bracing and Distraction System

K-Number: K161751 · 2016-09-02

ApplicantNuvasive Specialized Orthopedics, Inc.
Decision Date2016-09-02
Product CodePGN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MAGEC® Spinal Bracing and Distraction System is a medical device manufactured by Nuvasive Specialized Orthopedics, Inc.. It received FDA 510(k) clearance on 2016-09-02 under approval number K161751. 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 2016-09-02. It is manufactured by Nuvasive Specialized Orthopedics, Inc.. The 510(k) number is K161751.

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

MAGEC® Spinal Bracing and Distraction System received FDA 510(k) clearance on 2016-09-02, under approval number K161751.

What company makes MAGEC® Spinal Bracing and Distraction System?

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

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.

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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, Inc.

K160352MAGEC® Spinal Bracing and Distraction System K173129PRECICE System K172628PRECICE System K172061PRECICE UNYTE System K170169PRECICE Intramedullary Limb Lengthening System K162927PRECICE UNYTE CoCr System

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Related Devices (Code: PGN)

K160352MAGEC® Spinal Bracing and Distraction SystemNuvasive Specialized Orthopedics, Inc. K171791MAGEC® SystemNuvasive Specialized Orthopedics, Incorporated K201543MAGEC® SystemNuvasive Specialized Orthopedics, Inc. K233593MAGEC Spinal Bracing and Distraction SystemNuvasive Specialized Orthopedics, Incorporated

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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