BEE HA Cage: FDA 510(k) K250560, NGMedical GmbH

Regulatory status

as of registry sync 7 Nov 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK250560	Date21 Nov 2025Decided	StatusActive
European Union	CE/MDR EUDAMED	Number42516314TD024III4L Basic UDI-DI	Date20 Oct 2025Registered	StatusActive
United States	GUDID listing GUDID	Number04251631404118 UDI-DI	Date10 Aug 2022Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE 510(k) Substantially Equivalent · Traditional	NumberK203444	Date18 Mar 2021Cleared	StatusActive

Official records

EUDAMED public site Basic UDI-DI 42516314TD024III4L — open Devices and search for it
AccessGUDID record UDI-DI 04251631404118
AccessGUDID record UDI-DI 04251631422495
FDA 510(k) database 510(k) number K250560
FDA 510(k) database 510(k) number K203444

Across registries

3 registries list this device

FDA 510(k) K250560 decided 21 Nov 2025 Active· +1 more in the status table
EUDAMED Basic UDI-DI 42516314TD024III4L registered 20 Oct 2025 Active
FDA GUDID UDI-DI 04251631404118 listed 10 Aug 2022 Listed

Certificates

1 certificate · EUDAMED

20396GB450260521 Active Supplemented

Technical documentation EU MDR

Certifier

DNV MEDCERT GmbH 0482

Issued
21 May 2026

Expires
20 May 2030

Reason
Add device or group

Timeline

4 dated events

18 Mar 2021 Cleared FDA 510(k) K203444
10 Aug 2022 Listed FDA GUDID 04251631404118
20 Oct 2025 Registered EUDAMED 42516314TD024III4L
21 Nov 2025 Cleared FDA 510(k) K250560

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDR Active
United States FDA 510(k) Active

Specification

EUDAMED · 510(k) · GUDID

Trade name: BEE HA Cage cervical 10x16 mm 4° EUDAMED
Bee Ha GUDID
Generic name: Polymeric spinal interbody fusion cage
Device name: "BEE Cage cervical" and "BEE HA Cage cervical"
Model / Ref / Catalog: BHA1016L4, Cervical 10x16 mm 4°

Primary DI / UDI-DI: 04251631404118, 04251631422495
Basic UDI-DI: 42516314TD024III4L
510(k) Number: K203444 510(k)
K250560 GUDID
FDA product code: ODP
EMDN code: P09070101 Spinal cages
GMDN term: Polymeric spinal interbody fusion cage

Device class: Class III EUDAMED
Class II 510(k)GUDID
Regulation: 21 CFR Part 888.3080
EU registration type: Standard device
EU market of registration: Germany
Advisory committee: Orthopedic
FDA decision: SESE Substantially Equivalent
GUDID distribution status: In Commercial Distribution

MRI safety: MR Unsafe

Truth per registry

3 sources · 3 fields differ

Field	EUDAMED	510(k)	GUDID
Model / reference	EUDAMED BHA1016L4	510(k) —	GUDID Cervical 10x16 mm 4°
510(k) Number	EUDAMED —	510(k) K203444	GUDID K250560
Device class	EUDAMED Class III	510(k) Class II	GUDID Class II

Device class is stated on each registry's own scale: Class III in the EU (EUDAMED), Class II in the US (FDA 510(k), FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

BEE Cages K200429 29 Jan 2021 FDA record · FDA summary
PATRIOT COLONIAL Spacer, SUSTAIN Spacer K173722 23 May 2018 FDA record · FDA summary
Ascendant TM Cervical Spacer System K150130 28 May 2015 FDA record · FDA summary
Talos-C(HA) Cervical Intervertebral Body Fusion Devices K142345 22 Feb 2015 FDA record · FDA summary

Cited by

Bee Ha K250560 21 Nov 2025 FDA record · FDA summary

Source: 510k-lineage (choiben314), CC BY 4.0

Similar devices in this category

Other devices filed under SPINAL CAGES.

Other devices from NGMedical GmbH

BEE cage cervical 5 x 12 mm 12° short

Class III
BEE cage cervical 7 x 12 mm 12° short

Class III
BEE cage cervical 6 x 12 mm 12° short

Class III
BEE cage cervical 7 x 12 mm 8° short

Class III

See all devices from NGMedical GmbH →

Properties

Supplied sterile
Single use
Implantable
Prescription use
Lot / batch number
Expiration date
Manufacturing date

Other properties (18, all answered No)