Duns Number:078293017
Device Description: Lor 16X14,6 deg Dual trials 9&10H
Catalog Number
-
Brand Name
TiGER SHARK Interbody Fusion System
Version/Model Number
D070-DS616140910
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
-
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
K172816
Product Code
MAX
Product Code Name
Intervertebral fusion device with bone graft, lumbar
Public Device Record Key
fac8553b-1c51-4f65-90fa-6a796a63227a
Public Version Date
June 28, 2019
Public Version Number
1
DI Record Publish Date
June 20, 2019
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 | 2373 |
2 | A medical device with a moderate to high risk that requires special controls. | 5754 |
U | Unclassified | 61 |