Duns Number:830350380
Device Description: SCREW PK2 G6633510 SA S-T 3.5mm x 10mm
Catalog Number
-
Brand Name
Divergence® Anterior Cervical Fusion System
Version/Model Number
G6633510
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 26, 2022
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
K141599,K141599
Product Code
OVE
Product Code Name
Intervertebral fusion device with integrated fixation, cervical
Public Device Record Key
df89ea67-b1c3-4e4f-9b28-243339f33f53
Public Version Date
October 13, 2022
Public Version Number
6
DI Record Publish Date
October 02, 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 | 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 |