MAGEC® System
K-Number: K201543 · 2020-07-30
Decision Date2020-07-30
Product CodePGN
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
MAGEC® System is a medical device manufactured by Nuvasive Specialized Orthopedics, Inc.. It received FDA 510(k) clearance on 2020-07-30 under approval 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. It is manufactured by Nuvasive Specialized Orthopedics, Inc.. The 510(k) number is K201543.
When was MAGEC® System approved by the FDA?
MAGEC® System received FDA 510(k) clearance on 2020-07-30, under approval number K201543.
What company makes MAGEC® System?
MAGEC® System is manufactured by Nuvasive Specialized Orthopedics, Inc..
What is the FDA product code for MAGEC® System?
The FDA product code for MAGEC® System is PGN.
Other Devices by Nuvasive Specialized Orthopedics, Inc.
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K171791MAGEC® SystemNuvasive Specialized Orthopedics, Incorporated
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.