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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 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 2016-10-21 under 510(k) 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. The listed applicant is Nuvasive Specialized Orthopedics, Inc.. The 510(k) number is K160352.

When did MAGEC® Spinal Bracing and Distraction System receive FDA 510(k) clearance?

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

Who is the listed applicant for MAGEC® Spinal Bracing and Distraction 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® Spinal Bracing and Distraction System?

The FDA product code for MAGEC® Spinal Bracing and Distraction 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, IncorporatedK201543MAGEC® SystemNuvasive Specialized Orthopedics, Inc.K171791MAGEC® SystemNuvasive Specialized Orthopedics, IncorporatedK161751MAGEC® 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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