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FDA 510(k)

PYRAMESH™ Implant System

K-Number: K183197 · 2019-04-04

ApplicantMedtronic Sofamor Danek USA, Inc.
Decision Date2019-04-04
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PYRAMESH™ Implant System 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 2019-04-04 under 510(k) number K183197. The device is classified under product code MQP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PYRAMESH™ Implant System?

PYRAMESH™ Implant System is a medical device that received FDA 510(k) clearance on 2019-04-04. The listed applicant is Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K183197.

When did PYRAMESH™ Implant System receive FDA 510(k) clearance?

PYRAMESH™ Implant System received FDA 510(k) clearance on 2019-04-04, under 510(k) number K183197.

Who is the listed applicant for PYRAMESH™ Implant System?

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 PYRAMESH™ Implant System?

The FDA product code for PYRAMESH™ Implant System is MQP.

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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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