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FDA 510(k)

MAGEC® Spinal Bracing and Distraction System

K-Number: K160352 · 2016-10-21

ApplicantNuvasive Specialized Orthopedics, Inc.
Decision Date2016-10-21
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 2016-10-21 under approval number K160352. 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 2016-10-21. It is manufactured by Nuvasive Specialized Orthopedics, Inc.. The 510(k) number is K160352.

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

MAGEC® Spinal Bracing and Distraction System received FDA 510(k) clearance on 2016-10-21, under approval number K160352.

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: 41612341 Brain-computer interface commercialization. Journal of neuroengineering and rehabilitation (2026) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

Other Devices by Nuvasive Specialized Orthopedics, Inc.

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Related Devices (Code: PGN)

K161751MAGEC® 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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