Duns Number:830350380
Device Description: TRIAL 66205278 NP PARALLEL 7-8X15X12
Catalog Number
-
Brand Name
Divergence® Anterior Cervical Fusion System
Version/Model Number
66205278
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
K141599
Product Code
OVE
Product Code Name
Intervertebral fusion device with integrated fixation, cervical
Public Device Record Key
7bb4115b-a988-4eb5-8a0a-8cdadb888c54
Public Version Date
February 07, 2019
Public Version Number
4
DI Record Publish Date
May 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 | 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 |