FUSE Spinal System
K-Number: K171468 · 2017-06-13
ApplicantMedtronic Sofamor Danek
Decision Date2017-06-13
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
FUSE Spinal System is a medical device manufactured by Medtronic Sofamor Danek. It received FDA 510(k) clearance on 2017-06-13 under approval number K171468. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the FUSE Spinal System?
FUSE Spinal System is a medical device that received FDA 510(k) clearance on 2017-06-13. It is manufactured by Medtronic Sofamor Danek. The 510(k) number is K171468.
When was FUSE Spinal System approved by the FDA?
FUSE Spinal System received FDA 510(k) clearance on 2017-06-13, under approval number K171468.
What company makes FUSE Spinal System?
FUSE Spinal System is manufactured by Medtronic Sofamor Danek.
What is the FDA product code for FUSE Spinal System?
The FDA product code for FUSE Spinal System is MAX.
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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.