MAGEC® System
K-Number: K171791 · 2017-08-31
Decision Date2017-08-31
Product CodePGN
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
MAGEC® System is a medical device manufactured by Nuvasive Specialized Orthopedics, Incorporated. It received FDA 510(k) clearance on 2017-08-31 under approval number K171791. 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 2017-08-31. It is manufactured by Nuvasive Specialized Orthopedics, Incorporated. The 510(k) number is K171791.
When was MAGEC® System approved by the FDA?
MAGEC® System received FDA 510(k) clearance on 2017-08-31, under approval number K171791.
What company makes MAGEC® System?
MAGEC® System is manufactured by Nuvasive Specialized Orthopedics, Incorporated.
What is the FDA product code for MAGEC® System?
The FDA product code for MAGEC® System is PGN.
Other Devices by Nuvasive Specialized Orthopedics, Incorporated
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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.