Duns Number:342615118
Device Description: BEE HA Cages were especially adapted to the local anatomy to secure the surgical outcome a
Catalog Number
BHA816L8
Brand Name
BEE HA Cage
Version/Model Number
Cervical 8x16 mm 8°
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
K203444
Product Code
ODP
Product Code Name
Intervertebral Fusion Device With Bone Graft, Cervical
Public Device Record Key
a9554bed-8a00-4c41-a77a-db70a8fa3dbe
Public Version Date
August 19, 2022
Public Version Number
1
DI Record Publish Date
August 11, 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 |