Duns Number:830350380
Device Description: SCREW PK2 G7733516 MiniP S-D 3.5mm x16mm
Catalog Number
-
Brand Name
Divergence® Anterior Cervical Fusion System
Version/Model Number
G7733516
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
K140417,K140417
Product Code
KWQ
Product Code Name
APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
Public Device Record Key
c5485c6f-c319-44ae-83f2-fcfa4599d158
Public Version Date
September 27, 2022
Public Version Number
6
DI Record Publish Date
April 14, 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 |