KYPHON HV-R Bone Cement
K-Number: K180700 · 2018-05-18
ApplicantMedtronic Sofamor Danek USA, Inc.
Decision Date2018-05-18
Product CodeNDN
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
KYPHON HV-R Bone Cement is a medical device manufactured by Medtronic Sofamor Danek USA, Inc.. It received FDA 510(k) clearance on 2018-05-18 under approval number K180700. 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 HV-R Bone Cement?
KYPHON HV-R Bone Cement is a medical device that received FDA 510(k) clearance on 2018-05-18. It is manufactured by Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K180700.
When was KYPHON HV-R Bone Cement approved by the FDA?
KYPHON HV-R Bone Cement received FDA 510(k) clearance on 2018-05-18, under approval number K180700.
What company makes KYPHON HV-R Bone Cement?
KYPHON HV-R Bone Cement is manufactured by Medtronic Sofamor Danek USA, Inc..
What is the FDA product code for KYPHON HV-R Bone Cement?
The FDA product code for KYPHON HV-R Bone Cement is NDN.
Other Devices by Medtronic Sofamor Danek USA, Inc.
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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.