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FDA 510(k)

Centerpiece Plate Fixation System

K-Number: K212428 · 2021-12-13

ApplicantMedtronic Sofamor Danek
Decision Date2021-12-13
Product CodeNQW
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Centerpiece Plate Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Sofamor Danek. It received FDA 510(k) clearance on 2021-12-13 under 510(k) number K212428. The device is classified under product code NQW. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Centerpiece Plate Fixation System?

Centerpiece Plate Fixation System is a medical device that received FDA 510(k) clearance on 2021-12-13. The listed applicant is Medtronic Sofamor Danek. The 510(k) number is K212428.

When did Centerpiece Plate Fixation System receive FDA 510(k) clearance?

Centerpiece Plate Fixation System received FDA 510(k) clearance on 2021-12-13, under 510(k) number K212428.

Who is the listed applicant for Centerpiece Plate Fixation System?

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

What is the FDA product code for Centerpiece Plate Fixation System?

The FDA product code for Centerpiece Plate Fixation System is NQW.

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Related Devices (Code: NQW)

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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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