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FDA 510(k)

VERTEX RCCONSTRUCTION SYSTEM

K-Number: K121191 · 2012-06-29

ApplicantMedtronic Sofamor Danek, Inc.
Decision Date2012-06-29
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VERTEX RCCONSTRUCTION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Sofamor Danek, Inc.. It received FDA 510(k) clearance on 2012-06-29 under 510(k) number K121191. The device is classified under product code KWP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VERTEX RCCONSTRUCTION SYSTEM?

VERTEX RCCONSTRUCTION SYSTEM is a medical device that received FDA 510(k) clearance on 2012-06-29. The listed applicant is Medtronic Sofamor Danek, Inc.. The 510(k) number is K121191.

When did VERTEX RCCONSTRUCTION SYSTEM receive FDA 510(k) clearance?

VERTEX RCCONSTRUCTION SYSTEM received FDA 510(k) clearance on 2012-06-29, under 510(k) number K121191.

Who is the listed applicant for VERTEX RCCONSTRUCTION SYSTEM?

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

What is the FDA product code for VERTEX RCCONSTRUCTION SYSTEM?

The FDA product code for VERTEX RCCONSTRUCTION SYSTEM is KWP.

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Related Devices (Code: KWP)

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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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