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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Sofamor Danek USA, Inc.. It received FDA 510(k) clearance on 2018-05-18 under 510(k) 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. The listed applicant is Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K180700.

When did KYPHON HV-R Bone Cement receive FDA 510(k) clearance?

KYPHON HV-R Bone Cement received FDA 510(k) clearance on 2018-05-18, under 510(k) number K180700.

Who is the listed applicant for KYPHON HV-R Bone Cement?

The FDA 510(k) record lists Medtronic Sofamor Danek USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

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