Duns Number:623316978
Device Description: Interbody Fusion Device nanoLOCK Surface Technology 12 Degree Hybrid 15mm
Catalog Number
2312-1115-N
Brand Name
Endoskeleton TAS
Version/Model Number
2312-1115-N
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 21, 2020
Issuing Agency
In HIBCC
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
K111626,K141953
Product Code
OVD
Product Code Name
Intervertebral fusion device with integrated fixation, lumbar
Public Device Record Key
b0d93d05-a7de-42de-b723-71f01aba581d
Public Version Date
December 09, 2020
Public Version Number
7
DI Record Publish Date
September 17, 2015
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 |