Duns Number:080386764
Device Description: Ti3D CAGE 32L x 12W x 17H
Catalog Number
-
Brand Name
NeoFuse Ti3D PLIF/TLIF
Version/Model Number
C3212-17
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 13, 2022
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
K170318
Product Code
MAX
Product Code Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Public Device Record Key
e035c010-9045-4cc1-ae5d-3ff86994933e
Public Version Date
July 15, 2022
Public Version Number
6
DI Record Publish Date
November 07, 2017
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 | 178 |
2 | A medical device with a moderate to high risk that requires special controls. | 414 |