FDA 510(k)

CancelleX Porous Titanium Lumbar Interbody Device

K-Nummer: K180373 · 2018-08-24

Entscheidungsdatum2018-08-24

ProduktcodeMAX

BeratungsausschussOR

EntscheidungSubstantially Equivalent

Produktübersicht

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 2018-08-24 under 510(k) number K180373. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

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 2018-08-24. The listed applicant is Xenco Medical, LLC. The 510(k) number is K180373.

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 2018-08-24, under 510(k) number K180373.

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.

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Weitere Einträge mit Xenco Medical, LLC als Antragsteller

K243673Xenco Medical CancelleX Cervical Interbody System K223059Xenco Medical InterAlign Cervical Interbody System K213456Xenco Medical Multilevel CerviKit K191074Sorrento Bone Graft Substitute K190364CancelleX Porous Titanium Lumbar Interbody Device K173933Sorrento Bioglass Bone Graft Substitute

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Verwandte Geräte (Code: MAX)

K261049SCALA® TLSpineart SA 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 SystemSeaSpine Orthopedics Corporation K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.

Offizielle Quelle

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