FDA 510(k)

Kyphon HV-R Bone Cement

K-Number: K160983 · 2016-08-24

Decision Date2016-08-24

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, Inc.. It received FDA 510(k) clearance on 2016-08-24 under 510(k) 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. The listed applicant is Medtronic, Inc.. The 510(k) number is K160983.

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

Kyphon HV-R Bone Cement received FDA 510(k) clearance on 2016-08-24, under 510(k) number K160983.

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

The FDA 510(k) record lists Medtronic, 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.