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FDA 510(k)

KYPH X HV-R BONE CEMENT

K-Number: K093828 · 2010-08-12

ApplicantMedtronic, Inc.
Decision Date2010-08-12
Product CodeNDN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

KYPH X 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 2010-08-12 under 510(k) number K093828. 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 KYPH X HV-R BONE CEMENT?

KYPH X HV-R BONE CEMENT is a medical device that received FDA 510(k) clearance on 2010-08-12. The listed applicant is Medtronic, Inc.. The 510(k) number is K093828.

When did KYPH X HV-R BONE CEMENT receive FDA 510(k) clearance?

KYPH X HV-R BONE CEMENT received FDA 510(k) clearance on 2010-08-12, under 510(k) number K093828.

Who is the listed applicant for KYPH X 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 KYPH X HV-R BONE CEMENT?

The FDA product code for KYPH X 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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