Duns Number:480789465
Device Description: icotec Lumbar Cage ETurn TLIF 10 x 12 mm
Catalog Number
13-57-12-32-10-ITi
Brand Name
icotec Lumbar Cage ETurn TLIF 10 x 12 mm
Version/Model Number
13-57-12-32-10-ITi
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
-
Product Code
MAX
Product Code Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Public Device Record Key
0974b51b-1232-4840-89d5-2c036fc46915
Public Version Date
August 16, 2018
Public Version Number
1
DI Record Publish Date
July 16, 2018
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. | 651 |