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.
Catalog Number
B1016L12
Brand Name
BEE Cage
Version/Model Number
Cervical 10x16 mm 12°
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
ODP
Product Code Name
Intervertebral Fusion Device With Bone Graft, Cervical
Public Device Record Key
6cae2ee8-183d-4534-94ca-d01fa97623f4
Public Version Date
August 17, 2022
Public Version Number
1
DI Record Publish Date
August 09, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |