Kyphon HV-R Bone Cement
K-Number: K160983 · 2016-08-24
ApplicantMedtronic, Inc.
Decision Date2016-08-24
Product CodeNDN
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Kyphon HV-R Bone Cement is a medical device manufactured by Medtronic, Inc.. It received FDA 510(k) clearance on 2016-08-24 under approval number K160983. 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 2016-08-24. It is manufactured by Medtronic, Inc.. The 510(k) number is K160983.
When was Kyphon HV-R Bone Cement approved by the FDA?
Kyphon HV-R Bone Cement received FDA 510(k) clearance on 2016-08-24, under approval number K160983.
What company makes Kyphon HV-R Bone Cement?
Kyphon HV-R Bone Cement is manufactured by Medtronic, 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.
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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.