Kyphon Xpede Bone Cement
K-Number: K163032 · 2017-02-27
ApplicantMedtronic, Inc.
Decision Date2017-02-27
Product CodeNDN
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Kyphon Xpede Bone Cement is a medical device manufactured by Medtronic, Inc.. It received FDA 510(k) clearance on 2017-02-27 under approval number K163032. The device is classified under product code NDN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Kyphon Xpede Bone Cement?
Kyphon Xpede Bone Cement is a medical device that received FDA 510(k) clearance on 2017-02-27. It is manufactured by Medtronic, Inc.. The 510(k) number is K163032.
When was Kyphon Xpede Bone Cement approved by the FDA?
Kyphon Xpede Bone Cement received FDA 510(k) clearance on 2017-02-27, under approval number K163032.
What company makes Kyphon Xpede Bone Cement?
Kyphon Xpede Bone Cement is manufactured by Medtronic, Inc..
What is the FDA product code for Kyphon Xpede Bone Cement?
The FDA product code for Kyphon Xpede Bone Cement is NDN.
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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.