BEE HA Cage - BEE HA Cages were especially adapted to the local - NGMedical GmbH

Duns Number:342615118

Device Description: BEE HA Cages were especially adapted to the local anatomy to secure the surgical outcome a 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.

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

BHA716L8

Brand Name

BEE HA Cage

Version/Model Number

Cervical 7x16 mm 8°

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K203444

Product Code Details

Product Code

ODP

Product Code Name

Intervertebral Fusion Device With Bone Graft, Cervical

Device Record Status

Public Device Record Key

432f2b79-8aa5-4fb1-a4de-8dce00cbba6a

Public Version Date

August 19, 2022

Public Version Number

1

DI Record Publish Date

August 11, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NGMEDICAL GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 166
2 A medical device with a moderate to high risk that requires special controls. 282