Duns Number:830350380
Device Description: NANO SPACER 7130-1218-N TLH 30D 22X45X18
Catalog Number
-
Brand Name
Endoskeleton™ TL Interbody System with Titan nanoLOCK™ Surface Technology
Version/Model Number
7130-1218-N
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
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
K191581,K192018
Product Code
OVD
Product Code Name
Intervertebral fusion device with integrated fixation, lumbar
Public Device Record Key
456416ed-43b1-4a4b-a97c-e9e23b8ba5f1
Public Version Date
June 24, 2021
Public Version Number
3
DI Record Publish Date
August 15, 2020
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 | 13352 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 26085 |
| 3 | A medical device with high risk that requires premarket approval | 190 |
| U | Unclassified | 75 |