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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 a medical device manufactured by Medtronic Sofamor Danek USA, Inc.. It received FDA 510(k) clearance on 2019-04-04 under approval 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. It is manufactured by Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K183197.

When was PYRAMESH™ Implant System approved by the FDA?

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

What company makes PYRAMESH™ Implant System?

PYRAMESH™ Implant System is manufactured by Medtronic Sofamor Danek USA, Inc..

What is the FDA product code for PYRAMESH™ Implant System?

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

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Related PubMed Literature

PMID: 39892748 Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study. Ophthalmology (2025) PMID: 41966145 From Registry to Reality: Opportunities to Enhance Post-market Surveillance of High-Risk Medical Devices Comment on "Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review". International journal of health policy and management (2025) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

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Related Devices (Code: 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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