COMET Lumbar Interbody Fusion Cage

Q: What is the product code of K191353?

The FDA product code is MAX – Intervertebral Fusion Device With Bone Graft, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.

FDA 510(k) K191353 · Baui Biotech Co., Ltd.

Substantially Equivalent

510(k) numberK191353

Submission

Device name: COMET Lumbar Interbody Fusion Cage
Applicant: Baui Biotech Co., Ltd.
New Taipei City, TW
Received: May 21, 2019
Decision date: April 14, 2020
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: MAX – Intervertebral Fusion Device With Bone Graft, Lumbar
Device class: Class II (moderate risk)
Regulation: 21 CFR 888.3080
Specialty: Orthopedic
Implant: Yes

Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

Other 510(k)s with product code MAX

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K261049	Scala® TLMAX · Traditional	Spineart SA	08/20/2026SE
K261430	TruLift Expandable SystemMAX · Traditional	Life Spine, Inc.	07/28/2026SE
K253011	Catalyft PL Expandable Interbody SystemMAX · Traditional	Medtronic Sofamor Danek USA, Inc.	07/17/2026SE
K261020	Symmetrix L Spinal SystemMAX · Traditional	Medtronic Sofamor Danek USA, Inc.	07/14/2026SE
K253420	Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…MAX · Traditional	SeaSpine Orthopedics Corporation	07/01/2026SE
K253151	Fule Interbody Fusion Cage SystemMAX · Traditional	Beijing Fule Science & Technology Development…	06/15/2026SE
K261159	Exceed® Biplanar Expandable Interbody SystemMAX · Traditional	Spine Wave, Inc.	05/29/2026SE
K253894	BMD Titanium Spinal Fusion SystemMAX · Traditional	Global Biomedica s.r.o.	05/28/2026SE
K260506	Ventana® P/T Lumbar Interbody SystemMAX · Traditional	Spinal Elements, Inc.	05/15/2026SE
K260837	VersaLift Expandable SystemMAX · Traditional	Life Spine, Inc.	05/12/2026SE

More from Life Spine, Inc.

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K191494	Facilis Spinal SystemNKB · Special	08/12/2019SE
K182416	NOVA Minimally Invasive SystemNKB · Abbreviated	06/11/2019SE
K161231	Facilis Spinal SystemNKB · Traditional	01/23/2017SE

Questions and answers

When was COMET Lumbar Interbody Fusion Cage cleared by the FDA?

COMET Lumbar Interbody Fusion Cage (K191353) received a 510(k) decision of Substantially Equivalent on April 14, 2020, 329 days after the submission was received.

What is the product code of K191353?

The FDA product code is MAX – Intervertebral Fusion Device With Bone Graft, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.