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FDA 510(k)

MECRON Cannulated Screw System

K-Number: K172213 · 2017-10-23

ApplicantMerete GmbH
Decision Date2017-10-23
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MECRON Cannulated Screw System is a medical device manufactured by Merete GmbH. It received FDA 510(k) clearance on 2017-10-23 under approval number K172213. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MECRON Cannulated Screw System?

MECRON Cannulated Screw System is a medical device that received FDA 510(k) clearance on 2017-10-23. It is manufactured by Merete GmbH. The 510(k) number is K172213.

When was MECRON Cannulated Screw System approved by the FDA?

MECRON Cannulated Screw System received FDA 510(k) clearance on 2017-10-23, under approval number K172213.

What company makes MECRON Cannulated Screw System?

MECRON Cannulated Screw System is manufactured by Merete GmbH.

What is the FDA product code for MECRON Cannulated Screw System?

The FDA product code for MECRON Cannulated Screw System is HWC. This falls under the Cardiovascular category.

Related Clinical Trials

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Related PubMed Literature

PMID: 38493931 Establishing finite element model credibility of a pedicle screw system under compression-bending: An end-to-end example of the ASME V&V 40 standard. Methods (San Diego, Calif.) (2024) PMID: 37209414 Adverse events associated with Aveir Journal of cardiovascular electrophysiology (2023) PMID: 30035086 Translational research of one dynamic hip screw system-from the SCI to the FDA. Journal of orthopaedic translation (2016)

Other Devices by Merete GmbH

K181026OsteoBridge™ IDSF System

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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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