Duns Number:623316978
Device Description: Interbody Fusion Device 12 Degree 60 (M/L) 22 (A/P) 16 mm
Catalog Number
7112-1516-N
Brand Name
ENDOSKELETON® TL nanoLOCK® Surface Technology
Version/Model Number
7112-1516-N
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 18, 2020
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
K140055,K141953
Product Code
MAX
Product Code Name
Intervertebral fusion device with bone graft, lumbar
Public Device Record Key
4995abee-4635-457b-9de4-987281568ba8
Public Version Date
December 09, 2020
Public Version Number
9
DI Record Publish Date
December 15, 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 | 243 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5255 |