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

Duns Number:342615118

Device Description: BEE Cages were especially adapted to the local anatomy to secure the surgical outcome at t BEE 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 form. The cage disposes of 4 pins on both bone facing surfaces, which serve the primary fixation. BEE implants are made of titanium alloy (Ti6Al4V) according to ASTM F 3001. BEE Cages are produced with selective laser melting (SLM) technique. It is not allowed to use BEE implants in contact with components of other manufacturers with the exception of bone graft substitutes or fillers.

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More Product Details

Catalog Number

B918L8

Brand Name

BEE Cage

Version/Model Number

Cervical 9x18 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

K200429

Product Code Details

Product Code

ODP

Product Code Name

Intervertebral Fusion Device With Bone Graft, Cervical

Device Record Status

Public Device Record Key

cc76b5d9-5ce3-420d-a862-79d9ef13f150

Public Version Date

August 17, 2022

Public Version Number

1

DI Record Publish Date

August 09, 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