BEE HA Cage BHA818L4

GUDID 04251631401841

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.

NGMedical GmbH

Polymeric spinal interbody fusion cage
Primary Device ID04251631401841
NIH Device Record Keye27290e1-d5ce-4a52-a7c1-ab97f9f12f63
Commercial Distribution StatusIn Commercial Distribution
Brand NameBEE HA Cage
Version Model NumberCervical 8x18 mm 4°
Catalog NumberBHA818L4
Company DUNS342615118
Company NameNGMedical GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104251631401841 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ODPIntervertebral Fusion Device With Bone Graft, Cervical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-08-19
Device Publish Date2022-08-11

On-Brand Devices [BEE HA Cage]

04251631404125BEE HA Cages were especially adapted to the local anatomy to secure the surgical outcome at the
04251631404200BEE HA Cages were especially adapted to the local anatomy to secure the surgical outcome at the
04251631404194BEE HA Cages were especially adapted to the local anatomy to secure the surgical outcome at the
04251631404187BEE HA Cages were especially adapted to the local anatomy to secure the surgical outcome at the
04251631404170BEE HA Cages were especially adapted to the local anatomy to secure the surgical outcome at the
04251631404163BEE HA Cages were especially adapted to the local anatomy to secure the surgical outcome at the
04251631404156BEE HA Cages were especially adapted to the local anatomy to secure the surgical outcome at the
04251631404149BEE HA Cages were especially adapted to the local anatomy to secure the surgical outcome at the
04251631404132BEE HA Cages were especially adapted to the local anatomy to secure the surgical outcome at the
04251631404118BEE HA Cages were especially adapted to the local anatomy to secure the surgical outcome at the
04251631403951BEE HA Cages were especially adapted to the local anatomy to secure the surgical outcome at the
04251631403944BEE HA Cages were especially adapted to the local anatomy to secure the surgical outcome at the
04251631403937BEE HA Cages were especially adapted to the local anatomy to secure the surgical outcome at the
04251631403920BEE HA Cages were especially adapted to the local anatomy to secure the surgical outcome at the
04251631403913BEE HA Cages were especially adapted to the local anatomy to secure the surgical outcome at the
04251631403906BEE HA Cages were especially adapted to the local anatomy to secure the surgical outcome at the
04251631403890BEE HA Cages were especially adapted to the local anatomy to secure the surgical outcome at the
04251631401797BEE HA Cages were especially adapted to the local anatomy to secure the surgical outcome at the
04251631401780BEE HA Cages were especially adapted to the local anatomy to secure the surgical outcome at the
04251631401773BEE HA Cages were especially adapted to the local anatomy to secure the surgical outcome at the
04251631401766BEE HA Cages were especially adapted to the local anatomy to secure the surgical outcome at the
04251631401759BEE HA Cages were especially adapted to the local anatomy to secure the surgical outcome at the
04251631404101BEE HA Cages were especially adapted to the local anatomy to secure the surgical outcome at the
04251631404095BEE HA Cages were especially adapted to the local anatomy to secure the surgical outcome at the
04251631404088BEE HA Cages were especially adapted to the local anatomy to secure the surgical outcome at the
04251631404071BEE HA Cages were especially adapted to the local anatomy to secure the surgical outcome at the
04251631404064BEE HA Cages were especially adapted to the local anatomy to secure the surgical outcome at the
04251631404057BEE HA Cages were especially adapted to the local anatomy to secure the surgical outcome at the
04251631404040BEE HA Cages were especially adapted to the local anatomy to secure the surgical outcome at the
04251631404033BEE HA Cages were especially adapted to the local anatomy to secure the surgical outcome at the
04251631404026BEE HA Cages were especially adapted to the local anatomy to secure the surgical outcome at the
04251631404019BEE HA Cages were especially adapted to the local anatomy to secure the surgical outcome at the
04251631404002BEE HA Cages were especially adapted to the local anatomy to secure the surgical outcome at the
04251631403999BEE HA Cages were especially adapted to the local anatomy to secure the surgical outcome at the
04251631403982BEE HA Cages were especially adapted to the local anatomy to secure the surgical outcome at the
04251631403975BEE HA Cages were especially adapted to the local anatomy to secure the surgical outcome at the
04251631403968BEE HA Cages were especially adapted to the local anatomy to secure the surgical outcome at the
04251631401841BEE HA Cages were especially adapted to the local anatomy to secure the surgical outcome at the
04251631401834BEE HA Cages were especially adapted to the local anatomy to secure the surgical outcome at the
04251631401827BEE HA Cages were especially adapted to the local anatomy to secure the surgical outcome at the
04251631401810BEE HA Cages were especially adapted to the local anatomy to secure the surgical outcome at the
04251631401803BEE HA Cages were especially adapted to the local anatomy to secure the surgical outcome at the
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.