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BEE Cervical Cage

by NGMedical GmbH

510(k) K231371

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK231371 Date12 Jan 2024ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
ODP
Device class
Class II
Regulation
21 CFR Part 888.3080
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The BEE Cervical Cage is a spinal interbody fusion device designed for cervical spine stabilization. Constructed with a 3D-printed titanium honeycomb structure, it promotes bone ingrowth and fusion while minimizing subsidence, enhancing long-term fixation in the cervical spine.

This device is supplied sterile and intended for single-use in surgical settings. It is classified under product code ODP (Orthopedic Devices, Spinal Fusion Systems) and has received FDA 510(k) clearance as substantially equivalent to predicate devices. The cage’s open design facilitates osseointegration, and its structural integrity is optimized for spinal alignment and stability.

Other devices from NGMedical GmbH

See all devices from NGMedical GmbH →

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the BEE Cervical Cage used for?

    The BEE Cervical Cage is a spinal interbody fusion device designed for cervical spine stabilization. Its 3D-printed titanium honeycomb structure promotes bone ingrowth and fusion while minimizing subsidence, enhancing long-term fixation in the cervical spine.

  • How is the BEE Cervical Cage supplied and can it be reused?

    The BEE Cervical Cage is supplied sterile and is intended for single-use only in surgical settings. It should not be reused or resterilized as this could compromise its structural integrity and sterility.

  • What regulatory approvals does the BEE Cervical Cage have?

    The BEE Cervical Cage has received FDA 510(k) clearance as substantially equivalent to predicate devices. It is classified under product code ODP (Orthopedic Devices, Spinal Fusion Systems) and was cleared through the traditional review pathway.

  • What makes the BEE Cervical Cage design unique?

    The cage features a 3D-printed titanium honeycomb structure that promotes osseointegration and minimizes subsidence. Its open design facilitates bone ingrowth while maintaining structural integrity optimized for spinal alignment and stability.