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FDA 510(k)

Biomet Fusion System

K-Number: K163543 · 2017-02-28

ApplicantZimmer Biomet Spine, Inc.
Decision Date2017-02-28
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Biomet Fusion System is a medical device manufactured by Zimmer Biomet Spine, Inc.. It received FDA 510(k) clearance on 2017-02-28 under approval number K163543. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Biomet Fusion System?

Biomet Fusion System is a medical device that received FDA 510(k) clearance on 2017-02-28. It is manufactured by Zimmer Biomet Spine, Inc.. The 510(k) number is K163543.

When was Biomet Fusion System approved by the FDA?

Biomet Fusion System received FDA 510(k) clearance on 2017-02-28, under approval number K163543.

What company makes Biomet Fusion System?

Biomet Fusion System is manufactured by Zimmer Biomet Spine, Inc..

What is the FDA product code for Biomet Fusion System?

The FDA product code for Biomet Fusion System is OVD.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT02161874 Evaluation of Integration Success and Crestal Bone Preservation Biomet 3i's T3 Implant System COMPLETED NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT06089291 Persona IQ Cohort Study ENROLLING_BY_INVITATION NCT04984291 Zimmer Biomet Shoulder Arthroplasty PMCF RECRUITING NCT04305925 Focal Laser Ablation of Prostate Cancer COMPLETED

Other Devices by Zimmer Biomet Spine, Inc.

K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument System K171907Vitality® Spinal Fixation System K180227Polaris Spinal Growth System K171495Zyston Strut Open Titanium Spacer System K191722Vital Navigation System K192133Zimmer Biomet Universal Navigation System

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Related Devices (Code: OVD)

K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc. K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation K161993Leva® Anterior Interbody SystemSpine Wave, Inc. K161379ELSA SpacersGlobus Medical, Inc. K161173Avenue® T TLIF CageLdr Spine USA, Inc. K161129PILLAR SA PTCOrthofix, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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