BEE HA Cage

FDA UDI

Class II (US FDA UDI)

by NGMedical GmbH

Identity

Trade Name: BEE HA Cage FDA UDI
Generic Name: Polymeric spinal interbody fusion cage FDA UDI
Device Name: BEE HA Cages were especially adapted to the local anatomy to secure the surgical outcome at the best. The caudal side is flat, the cranial side is domed and the implants formed conically from anterior to posterior. In the lateral view, the implant has a slightly lordotic form. The cage disposes of 4 pins on both bone facing surfaces. BEE HA implants are made of PEEK-OPTIMA HA ENHANCED and pins made out of titanium alloy (Ti6Al4V) according to ASTM F136. It is not allowed to use BEE HA implants in contact with components of other manufacturers. FDA UDI
Model / Reference: Cervical 9x16 mm 8° FDA UDI
Description: BEE HA Cages were especially adapted to the local anatomy to secure the surgical outcome at the best. The caudal side is flat, the cranial side is domed and the implants formed conically from anterior to posterior. In the lateral view, the implant has a slightly lordotic form. The cage disposes of 4 pins on both bone facing surfaces. BEE HA implants are made of PEEK-OPTIMA HA ENHANCED and pins made out of titanium alloy (Ti6Al4V) according to ASTM F136. It is not allowed to use BEE HA implants in contact with components of other manufacturers. FDA UDI

Identifiers

Catalog Number: BHA916L8 FDA UDI
Primary DI / UDI-DI: 04251631404071 FDA UDI
510(k) Number: K203444 FDA UDI
FDA Product Code: ODP FDA UDI
GMDN Term: Polymeric spinal interbody fusion cage FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3080 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Polymeric spinal interbody fusion cage

BEE HA Cage by NGMedical GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Polymeric spinal interbody fusion cage.

L-Box® — Innovasis, Inc. · Class II
CoRoent — Nuvasive, Inc. · Class II
Novel Spinal Spacer System — ALPHATEC SPINE, INC. · Class II
S-LIFT® — SPINEFRONTIER, INC. · Class II
Peridot Intervertebral body fusion system — GBS Commonwealth Co., Ltd. · Class II
TAURUS PEEK Cage System — Medyssey Co., Ltd. · Class II
Cross-Fuse® II PEEK IBF System — Rti Surgical, Inc. · Class II
Kyocera Medical Technologies, Inc. — Kyocera Medical Technologies, Inc. · Class II

Cleared under the same submission

K203444 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: NGMedical GmbH

Sources (1)

FDA UDI c1d6e250-ee12-420d-b1c2-52ce4f7fc074 37 fields · synced Jun 8, 2026