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FDA 510(k)

VerteFIT Corpectomy Cage System

K-Number: K162133 · 2017-05-16

ApplicantLdr Spine USA, Inc.
Decision Date2017-05-16
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VerteFIT Corpectomy Cage System is the device name listed in this FDA 510(k) record. The listed applicant is Ldr Spine USA, Inc.. It received FDA 510(k) clearance on 2017-05-16 under 510(k) number K162133. 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 VerteFIT Corpectomy Cage System?

VerteFIT Corpectomy Cage System is a medical device that received FDA 510(k) clearance on 2017-05-16. The listed applicant is Ldr Spine USA, Inc.. The 510(k) number is K162133.

When did VerteFIT Corpectomy Cage System receive FDA 510(k) clearance?

VerteFIT Corpectomy Cage System received FDA 510(k) clearance on 2017-05-16, under 510(k) number K162133.

Who is the listed applicant for VerteFIT Corpectomy Cage System?

The FDA 510(k) record lists Ldr Spine USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VerteFIT Corpectomy Cage System?

The FDA product code for VerteFIT Corpectomy Cage System is MQP.

Other records listing Ldr Spine USA, 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.

K161173Avenue® T TLIF CageK161798FacetBRIDGE® SystemK153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T Implant SystemK152137FacetBRIDGE 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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