FDA 510(k)

COMET Lumbar Interbody Fusion Cage

K-Number: K191353 · 2020-04-14

Decision Date2020-04-14

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

COMET Lumbar Interbody Fusion Cage is the device name listed in this FDA 510(k) record. The listed applicant is Baui Biotech Co., Ltd.. It received FDA 510(k) clearance on 2020-04-14 under 510(k) number K191353. 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 COMET Lumbar Interbody Fusion Cage?

COMET Lumbar Interbody Fusion Cage is a medical device that received FDA 510(k) clearance on 2020-04-14. The listed applicant is Baui Biotech Co., Ltd.. The 510(k) number is K191353.

When did COMET Lumbar Interbody Fusion Cage receive FDA 510(k) clearance?

COMET Lumbar Interbody Fusion Cage received FDA 510(k) clearance on 2020-04-14, under 510(k) number K191353.

Who is the listed applicant for COMET Lumbar Interbody Fusion Cage?

The FDA 510(k) record lists Baui Biotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COMET Lumbar Interbody Fusion Cage?

The FDA product code for COMET Lumbar Interbody Fusion Cage 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.

NCT07777718Lumbar Fusion With Nanotube Versus Titanium CageNOT_YET_RECRUITING NCT04214535Anterior Cervical Disectomy And Fusion Using The Tritanium® C Anterior Cervical Cage For One Or Two-LevelsACTIVE_NOT_RECRUITING NCT048238583Spine Lumbar Fusion Real World Evidence StudyACTIVE_NOT_RECRUITING NCT05237908Clinical Outcome and Fusion Rate of 3D Printed Interbody Fusion Cages and Titanium Coated PEEK CagesACTIVE_NOT_RECRUITING NCT05438719MOTUS Total Joint Replacement Investigational Device Exemption StudyACTIVE_NOT_RECRUITING NCT05583864Lumbar Fusion With Porous Versus Non-Porous CagesACTIVE_NOT_RECRUITING

Other records listing Baui Biotech Co., Ltd. as applicant

K242899NOVA Minimally Invasive System K191494Facilis™ Spinal System K182416NOVA Minimally Invasive System K161231Facilis™ Spinal System

Related Devices (Code: MAX)

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 Corporation K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.

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.