BEE HA

Primary DI
04251631401759
Brand
BEE HA
Company
NGMedical GmbH
Model
Cervical 4x16 mm 4°
Catalog number
BHA416L4
Device 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 implant is formed conically from anterior to posterior. In the lateral view, the implant has a slightly lordotic formand is available in 4°, 8° and 12° lordosis. The cage disposes of4 pins on both bone facing surfaces. BEE® HA implants are made of PEEK-OPTIMA®HA ENHANCED and pins made out of titanium alloy (Ti6Al4V_ELI) according to ASTMF136. It is not allowed to use BEE® HA implants in contact with components of other manufacturers with the exception of autogenous and/or allogeneic bone graft comprised of cancellous and/or coricocancellous bone graft.
Published
2022-08-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
ODPIntervertebral Fusion Device With Bone Graft, Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ODPIntervertebral Fusion Device With Bone Graft, CervicalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203444000
K250560000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203444000BEE HA CageNGMedical GmbH2021-03-18ODP
K250560000BEE HANGMedical GmbH2025-11-21ODP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04251631401759PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251631401759042516314017594251631401759

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
342615118
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04251631415138BEE HACervical 4x14mm 4°SBHA414L4S2026-04-21
04251631415145BEE HACervical 4x14mm 8°SBHA414L8S2026-04-21
04251631415152BEE HACervical 4x14mm 12°SBHA414L12S2026-04-21
04251631415169BEE HACervical 5x14mm 4°SBHA514L4S2026-04-21
04251631415176BEE HACervical 5x14mm 8°SBHA514L8S2026-04-21
04251631415183BEE HACervical 5x14mm 12°SBHA514L12S2026-04-21
04251631415190BEE HACervical 6x14mm 4°SBHA614L4S2026-04-21
04251631415206BEE HACervical 6x14mm 8°SBHA614L8S2026-04-21
04251631415213BEE HACervical 6x14mm 12°SBHA614L12S2026-04-21
04251631415220BEE HACervical 7x14mm 4°SBHA714L4S2026-04-21
04251631415237BEE HACervical 7x14mm 8°SBHA714L8S2026-04-21
04251631415244BEE HACervical 7x14mm 12°SBHA714L12S2026-04-21
04251631415251BEE HACervical 8x14mm 4°SBHA814L4S2026-04-21
04251631415268BEE HACervical 8x14mm 8°SBHA814L8S2026-04-21
04251631415275BEE HACervical 8x14mm 12°SBHA814L12S2026-04-21
04251631415282BEE HACervical 9x14mm 4°SBHA914L4S2026-04-21
04251631415299BEE HACervical 9x14mm 8°SBHA914L8S2026-04-21
04251631415305BEE HACervical 9x14mm 12°SBHA914L12S2026-04-21
04251631415312BEE HACervical 10x14mm 4°SBHA1014L4S2026-04-21
04251631415329BEE HACervical 10x14mm 8°SBHA1014L8S2026-04-21

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