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FDA 510(k)

MediExpand TL Expandable VBR System

K-Number: K190349 · 2019-10-24

ApplicantCmf Medicon Surgical, Inc.
Decision Date2019-10-24
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MediExpand TL Expandable VBR System is the device name listed in this FDA 510(k) record. The listed applicant is Cmf Medicon Surgical, Inc.. It received FDA 510(k) clearance on 2019-10-24 under 510(k) number K190349. 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 MediExpand TL Expandable VBR System?

MediExpand TL Expandable VBR System is a medical device that received FDA 510(k) clearance on 2019-10-24. The listed applicant is Cmf Medicon Surgical, Inc.. The 510(k) number is K190349.

When did MediExpand TL Expandable VBR System receive FDA 510(k) clearance?

MediExpand TL Expandable VBR System received FDA 510(k) clearance on 2019-10-24, under 510(k) number K190349.

Who is the listed applicant for MediExpand TL Expandable VBR System?

The FDA 510(k) record lists Cmf Medicon Surgical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MediExpand TL Expandable VBR System?

The FDA product code for MediExpand TL Expandable VBR System is MQP.

Other records listing Cmf Medicon Surgical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241253Medicon Epiplating SystemK242764MediRod Pedicle Screw SystemK212126MediExpand Cervical Expandable VBR System

Related Devices (Code: MQP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261810Vertiwedge® Intraosseous SystemFoundation Surgical GroupK261031POSEIDON STSignus Medinzintechnik GmbHK253158VyBrate™ VBR SystemVy Spine, LLCK241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AGK233359DOMINION Expandable Corpectomy SystemAstura Medical

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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