Duns Number:071012634
Device Description: Spann LLIF Cage 55x24x12mm 7 degrees
Catalog Number
LPSL 55-24-12-7
Brand Name
Epiphany
Version/Model Number
1
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
Labeling does not contain MRI Safety Information
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
-
Product Code
MAX
Product Code Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Public Device Record Key
58f575e6-b04b-413d-af66-a3fecea055a8
Public Version Date
June 02, 2020
Public Version Number
1
DI Record Publish Date
May 25, 2020
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 2121 |