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510(k) K254105

Hive™ Standalone Cervical System and Hive™ C Interbody System by NanoHive Medical, LLC — Product Code ODP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 2026
Date Received
December 19, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intervertebral Fusion Device With Bone Graft, Cervical
Device Class
Class II
Regulation Number
888.3080
Review Panel
OR
Submission Type

Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

Other clearances by NanoHive Medical, LLC

  • K231241 — NanoHive Medical Lumbar Interbody System (July 12, 2023)
  • K223190 — Hive™ Standalone Cervical System (December 12, 2022)

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  • K252894 — aprevo® cervical interbody system (January 6, 2026)
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