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FDA 510(k)

MediExpand Cervical Expandable VBR System

K-Number: K212126 · 2022-04-04

ApplicantCmf Medicon Surgical, Inc.
Decision Date2022-04-04
Product CodePLR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MediExpand Cervical 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 2022-04-04 under 510(k) number K212126. The device is classified under product code PLR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MediExpand Cervical Expandable VBR System?

MediExpand Cervical Expandable VBR System is a medical device that received FDA 510(k) clearance on 2022-04-04. The listed applicant is Cmf Medicon Surgical, Inc.. The 510(k) number is K212126.

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

MediExpand Cervical Expandable VBR System received FDA 510(k) clearance on 2022-04-04, under 510(k) number K212126.

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

The FDA product code for MediExpand Cervical Expandable VBR System is PLR.

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 SystemK190349MediExpand TL Expandable VBR System

Related Devices (Code: PLR)

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.

K252822Atlas Spine HiRISE™ Expandable Cervical-p Corpectomy ImplantAtlas Spine, Inc.K252560Atlas Spine HiRISE™ Expandable Cervical Corpectomy SystemAtlas Spine, Inc.K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLCK221542Galileo Vertebral Body Replacement DeviceBright SpineK211320CAPRI Corpectomy Cage SystemK2m, Inc.K192145Galileo Vertebral Body Replacement DeviceBright Spine

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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