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FDA 510(k)

Hive™ Stand-alone Anterior Lumbar Interbody System

K-Number: K200541 · 2020-04-28

ApplicantHd Lifesciences, LLC
Decision Date2020-04-28
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Hive™ Stand-alone Anterior Lumbar Interbody System is a medical device manufactured by Hd Lifesciences, LLC. It received FDA 510(k) clearance on 2020-04-28 under approval number K200541. 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 Hive™ Stand-alone Anterior Lumbar Interbody System?

Hive™ Stand-alone Anterior Lumbar Interbody System is a medical device that received FDA 510(k) clearance on 2020-04-28. It is manufactured by Hd Lifesciences, LLC. The 510(k) number is K200541.

When was Hive™ Stand-alone Anterior Lumbar Interbody System approved by the FDA?

Hive™ Stand-alone Anterior Lumbar Interbody System received FDA 510(k) clearance on 2020-04-28, under approval number K200541.

What company makes Hive™ Stand-alone Anterior Lumbar Interbody System?

Hive™ Stand-alone Anterior Lumbar Interbody System is manufactured by Hd Lifesciences, LLC.

What is the FDA product code for Hive™ Stand-alone Anterior Lumbar Interbody System?

The FDA product code for Hive™ Stand-alone Anterior Lumbar Interbody System is OVD.

Related Clinical Trials

NCT07301385 Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Safety and Workflow Study ACTIVE_NOT_RECRUITING NCT05701917 DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis RECRUITING NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07613476 Pregabalin Phonophoresis for Carpal Tunnel Syndrome Pain ACTIVE_NOT_RECRUITING NCT05677100 Diuretics Alone vs. Aortix Endovascular Device for Acute Heart Failure RECRUITING NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING

Related PubMed Literature

PMID: 41166829 Assessment of intra-operative impact durability of additively manufactured mock lumbar intervertebral body fusion devices. Journal of biomechanics (2026)

Other Devices by Hd Lifesciences, LLC

K170676HD Lumbar Interbody System K180364HD LifeSciences Cervical IBFD System

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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