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FDA 510(k)

MAGEC® System

K-Number: K201543 · 2020-07-30

ApplicantNuvasive Specialized Orthopedics, Inc.
Decision Date2020-07-30
Product CodePGN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MAGEC® System is the device name listed in this FDA 510(k) record. The listed applicant is Nuvasive Specialized Orthopedics, Inc.. It received FDA 510(k) clearance on 2020-07-30 under 510(k) number K201543. 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® System?

MAGEC® System is a medical device that received FDA 510(k) clearance on 2020-07-30. The listed applicant is Nuvasive Specialized Orthopedics, Inc.. The 510(k) number is K201543.

When did MAGEC® System receive FDA 510(k) clearance?

MAGEC® System received FDA 510(k) clearance on 2020-07-30, under 510(k) number K201543.

Who is the listed applicant for MAGEC® System?

The FDA 510(k) record lists Nuvasive Specialized Orthopedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAGEC® System?

The FDA product code for MAGEC® System is PGN.

Other records listing Nuvasive Specialized Orthopedics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261651Precice™ Max System and Precice™ Ankle Salvage SystemK233593MAGEC Spinal Bracing and Distraction SystemK232267Precice Max SystemK230765Precice Ankle Salvage SystemK220234Precice Intramedullary Limb Lengthening SystemK202348External Remote Controller ERC 4P

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Related Devices (Code: PGN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233593MAGEC Spinal Bracing and Distraction SystemNuvasive Specialized Orthopedics, IncorporatedK171791MAGEC® SystemNuvasive Specialized Orthopedics, IncorporatedK160352MAGEC® Spinal Bracing and Distraction SystemNuvasive Specialized Orthopedics, Inc.K161751MAGEC® Spinal Bracing and Distraction 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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