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Bee Ha

by NGMedical GmbH

510(k) K250560

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 NumberK250560 Date21 Nov 2025ClearedStatusActive

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  • Withdrawn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, 25 Sep 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 HA Cage Cervical is a spinal implant device made of PEEK-OPTIMA HA ENHANCED material with titanium alloy (Ti6Al4V) pins according to ASTM F136. It is designed for cervical spinal fusion procedures and comes in various sizes including 8x18 mm 8° and 6x18 mm 4° configurations.

The device is supplied as a single-use implant and should not be used in contact with components from other manufacturers. It is regulated under FDA 510(k) clearance with product code ODP and K-number K250560. The device is stored according to manufacturer specifications and requires proper handling to maintain its integrity before implantation.

Other devices from NGMedical GmbH

See all devices from NGMedical GmbH →

Questions

AI-generated answers, 25 Sep 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 HA Cage Cervical used for?

    The BEE HA Cage Cervical is a spinal implant device designed for cervical spinal fusion procedures. It is made of PEEK-OPTIMA HA ENHANCED material with titanium alloy pins and comes in various sizes to accommodate different patient anatomies.

  • How is the BEE HA Cage Cervical supplied?

    The device is supplied as a single-use implant and should not be used in contact with components from other manufacturers. It requires proper handling to maintain its integrity before implantation according to manufacturer specifications.

  • What sizes and configurations are available for the BEE HA Cage Cervical?

    The BEE HA Cage Cervical is available in various sizes including 8x18 mm 8° and 6x18 mm 4° configurations to accommodate different patient anatomies and surgical requirements.

  • What is the regulatory status of the BEE HA Cage Cervical?

    The BEE HA Cage Cervical is regulated under FDA 510(k) clearance with product code ODP and K-number K250560. It has been determined to be substantially equivalent to predicate devices.