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Comet Lumbar Interbody Fusion Cage

FDA 510(k)

Class II (US FDA 510(k))

510(k) K191353

by Baui Biotech Co. Ltd.

Identifiers

510(k) Number
K191353 FDA 510(k)
FDA Product Code
MAX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3080 FDA 510(k)
Regulation Number
888.3080 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Comet Lumbar Interbody Fusion Cage is a hollow, bullet-shaped spinal implant designed for intervertebral body fusion via a transforaminal posterior lumbar approach. It features a bullet nose design for ease of impaction and serrated surfaces to assist with fixation. The hollow center is intended to hold autogenous bone graft to promote fusion, while the curved shape is designed to strengthen triangular stability when used with a posterior fixation system.

This device is indicated for use in less invasive techniques such as MIS-TLIF. It has received FDA 510k clearance under K191353. Specific details regarding sterility, storage, and material composition are not provided.

Frequently asked questions

What is the primary clinical application for the COMET Lumbar Interbody Fusion Cage?

This device is designed for intervertebral body fusion using a transforaminal posterior lumbar approach. It is specifically indicated for use in less invasive surgical techniques, such as MIS-TLIF, to provide spinal stability.

How does the design of the cage assist with surgical implantation and stability?

The cage features a bullet-nose design to facilitate ease of impaction during surgery. Additionally, it includes serrated surfaces to assist with fixation and a curved shape intended to strengthen triangular stability when used in conjunction with a posterior fixation system.

What is the purpose of the hollow center in the COMET cage?

The hollow center of the implant is designed to hold autogenous bone graft. This space allows for the placement of bone material to promote the fusion process between the vertebral bodies.

What is the regulatory status of this spinal implant?

The COMET Lumbar Interbody Fusion Cage has received FDA 510k clearance under K191353. This indicates that the device has been found substantially equivalent to legally marketed predicate devices.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: COMET Lumbar Interbody Fusion Cage | BAUI Biotech, COMET Lumbar Interbody Fusion Cage (K191353) - Innolitics, PRODUCTS - BAUI Biotech

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Baui Biotech Co. Ltd.
FDA Applicant
Baui Biotech Co., Ltd.

Sources (1)

  • FDA 510(k) K191353 24 fields · synced Sep 21, 2026