Duns Number:079398589
Device Description: ALIF CAGE 8 DEG - 11MM (QTY 27 )
Catalog Number
ALIF0826-11P
Brand Name
INTERBODY FUSION
Version/Model Number
7086PM000
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
K080314
Product Code
KWQ
Product Code Name
Appliance, Fixation, Spinal Intervertebral Body
Public Device Record Key
f0b18b03-26d4-4911-9a70-b863b9d2810a
Public Version Date
February 24, 2020
Public Version Number
4
DI Record Publish Date
December 05, 2016
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 | 1423 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4960 |
| U | Unclassified | 26 |