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FDA 510(k)

CancelleX Porous Titanium Lumbar Interbody Device

K-Number: K190364 · 2019-04-18

ApplicantXenco Medical, LLC
Decision Date2019-04-18
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CancelleX Porous Titanium Lumbar Interbody Device is the device name listed in this FDA 510(k) record. The listed applicant is Xenco Medical, LLC. It received FDA 510(k) clearance on 2019-04-18 under 510(k) number K190364. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CancelleX Porous Titanium Lumbar Interbody Device?

CancelleX Porous Titanium Lumbar Interbody Device is a medical device that received FDA 510(k) clearance on 2019-04-18. The listed applicant is Xenco Medical, LLC. The 510(k) number is K190364.

When did CancelleX Porous Titanium Lumbar Interbody Device receive FDA 510(k) clearance?

CancelleX Porous Titanium Lumbar Interbody Device received FDA 510(k) clearance on 2019-04-18, under 510(k) number K190364.

Who is the listed applicant for CancelleX Porous Titanium Lumbar Interbody Device?

The FDA 510(k) record lists Xenco Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CancelleX Porous Titanium Lumbar Interbody Device?

The FDA product code for CancelleX Porous Titanium Lumbar Interbody Device is MAX.

Related Clinical Trials

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.

NCT05583864Lumbar Fusion With Porous Versus Non-Porous CagesACTIVE_NOT_RECRUITINGNCT05237908Clinical Outcome and Fusion Rate of 3D Printed Interbody Fusion Cages and Titanium Coated PEEK CagesACTIVE_NOT_RECRUITINGNCT07777718Lumbar Fusion With Nanotube Versus Titanium CageNOT_YET_RECRUITING

Other records listing Xenco Medical, LLC 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.

K243673Xenco Medical CancelleX Cervical Interbody SystemK223059Xenco Medical InterAlign Cervical Interbody SystemK213456Xenco Medical Multilevel CerviKitK191074Sorrento Bone Graft SubstituteK173933Sorrento Bioglass Bone Graft SubstituteK180373CancelleX Porous Titanium Lumbar Interbody Device

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Related Devices (Code: MAX)

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.

K261430TruLift Expandable SystemLife Spine, Inc.K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody SySeaSpine Orthopedics CorporationK253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.

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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