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FDA 510(k)

BEE HA

K-Number: K250560 · 2025-11-21

ApplicantNGMedical GmbH
Decision Date2025-11-21
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BEE HA is a medical device manufactured by NGMedical GmbH. It received FDA 510(k) clearance on 2025-11-21 under approval number K250560. 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 BEE HA?

BEE HA is a medical device that received FDA 510(k) clearance on 2025-11-21. It is manufactured by NGMedical GmbH. The 510(k) number is K250560.

When was BEE HA approved by the FDA?

BEE HA received FDA 510(k) clearance on 2025-11-21, under approval number K250560.

What company makes BEE HA?

BEE HA is manufactured by NGMedical GmbH.

What is the FDA product code for BEE HA?

The FDA product code for BEE HA is ODP.

Other Devices by NGMedical GmbH

K212050NGM WAVE PLIF Cage K211413BEE PLIF Cage K203444BEE HA Cage K200429BEE Cages K231371BEE Cervical Cage K261067BEE PLIF Cage

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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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