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 a medical device manufactured by Baui Biotech Co., Ltd.. It received FDA 510(k) clearance on 2020-04-14 under approval 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. It is manufactured by Baui Biotech Co., Ltd.. The 510(k) number is K191353.

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

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

What company makes COMET Lumbar Interbody Fusion Cage?

COMET Lumbar Interbody Fusion Cage is manufactured by Baui Biotech Co., Ltd..

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

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT06462729 LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF) RECRUITING NCT05438719 MOTUS Total Joint Replacement Investigational Device Exemption Study ACTIVE_NOT_RECRUITING NCT04823858 3Spine Lumbar Fusion Real World Evidence Study ACTIVE_NOT_RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT07017634 Efficacy and Safety of Novosis Putty in Transforaminal Lumbar Interbody Fusion for Patients With Lumbar Degenerative Disc Disease RECRUITING

Related PubMed Literature

PMID: 41839575 A Perspective for Integrating Real-World Evidence Into the Investigational Device Exemption Study Design for Lumbar Total Joint Replacement. International journal of spine surgery (2026) PMID: 41166829 Assessment of intra-operative impact durability of additively manufactured mock lumbar intervertebral body fusion devices. Journal of biomechanics (2026)

Other Devices by Baui Biotech Co., Ltd.

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

Related Devices (Code: MAX)

K163180Hubble IIOrbbo Surgical, LLC K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion SystemOrthofix, Inc. K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL K162103Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon), Choice Spine Interbody Fusion System (Harrier), Choice Spine Vertebral Body Replacement System (Hawkeye)Choicespine, LP K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc. K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, 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.