FDA 510(k)

Hive Standalone Cervical System and Hive C Interbody System

K-Number: K254105 · 2026-02-13

Decision Date2026-02-13

Product CodeODP

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Hive Standalone Cervical System and Hive C Interbody System is a medical device manufactured by NanoHive Medical, LLC. It received FDA 510(k) clearance on 2026-02-13 under approval number K254105. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Hive Standalone Cervical System and Hive C Interbody System?

Hive Standalone Cervical System and Hive C Interbody System is a medical device that received FDA 510(k) clearance on 2026-02-13. It is manufactured by NanoHive Medical, LLC. The 510(k) number is K254105.

When was Hive Standalone Cervical System and Hive C Interbody System approved by the FDA?

Hive Standalone Cervical System and Hive C Interbody System received FDA 510(k) clearance on 2026-02-13, under approval number K254105.

What company makes Hive Standalone Cervical System and Hive C Interbody System?

Hive Standalone Cervical System and Hive C Interbody System is manufactured by NanoHive Medical, LLC.

What is the FDA product code for Hive Standalone Cervical System and Hive C Interbody System?

The FDA product code for Hive Standalone Cervical System and Hive C Interbody System is ODP.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07606196 The Effect of Otolith Dysfunction and Its Rehabilitation in Vestibular Diseases COMPLETED NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT05489822 PMCF Study to Evaluate the VERTICALE® Cervical System in Spine Surgery According to Its Intended Use. TERMINATED NCT07153536 Spinal Cord Stimulation Combined With Physical Therapy in Post-Stroke Upper-Limb Motor Hemiparesis RECRUITING NCT05305430 Real World Data Collection on the Synergy Cervical Disc RECRUITING

Other Devices by NanoHive Medical, LLC

K223190Hive Standalone Cervical System K231241NanoHive Medical Lumbar Interbody System

Related Devices (Code: ODP)

K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc. K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc. K162220DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) CageDio Medical Co., Ltd. K161649Virtu C Spinal Implant SystemMet 1 Technologies, LLC

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.