FDA 510(k)

Biomet Spine Fusion System

K-Number: K153695 · 2016-01-21

Decision Date2016-01-21

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Biomet Spine Fusion System is a medical device manufactured by Biomet Spine, LLC. It received FDA 510(k) clearance on 2016-01-21 under approval number K153695. 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 Biomet Spine Fusion System?

Biomet Spine Fusion System is a medical device that received FDA 510(k) clearance on 2016-01-21. It is manufactured by Biomet Spine, LLC. The 510(k) number is K153695.

When was Biomet Spine Fusion System approved by the FDA?

Biomet Spine Fusion System received FDA 510(k) clearance on 2016-01-21, under approval number K153695.

What company makes Biomet Spine Fusion System?

Biomet Spine Fusion System is manufactured by Biomet Spine, LLC.

What is the FDA product code for Biomet Spine Fusion System?

The FDA product code for Biomet Spine Fusion System is MAX.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05438719 MOTUS Total Joint Replacement Investigational Device Exemption Study ACTIVE_NOT_RECRUITING NCT02161874 Evaluation of Integration Success and Crestal Bone Preservation Biomet 3i's T3 Implant System COMPLETED NCT07589023 A Retrospective Review: Outcomes of the REFLECT™ System for Idiopathic Scoliosis NOT_YET_RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT06938607 Post-operative Outcomes of Anterior Cervical Discectomy and Fusion Surgery With and Without Drain Placement NOT_YET_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)

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.