Duns Number:117201206
Device Description: Lumbar Interbody Fusion System (OLLIF) Graft Delivery Tube
Catalog Number
01-08
Brand Name
Lumbar Interbody Fusion System (OLLIF)
Version/Model Number
01-08
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
-
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
K173947
Product Code
MAX
Product Code Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Public Device Record Key
f5a73f74-df6f-4adf-89c1-816b15809e58
Public Version Date
December 07, 2021
Public Version Number
1
DI Record Publish Date
November 29, 2021
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 | 7 |
2 | A medical device with a moderate to high risk that requires special controls. | 103 |