Duns Number:830350380
Device Description: TRIAL 77365212 DIVERGE 6 DEG 11-12X15X12
Catalog Number
-
Brand Name
DIVERGENCE™ ANTERIOR CERVICAL FUSION SYSTEM
Version/Model Number
77365212
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
-
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
K142450
Product Code
KWQ
Product Code Name
APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
Public Device Record Key
e7361f13-bdf8-461b-a162-ee7235ebe305
Public Version Date
October 13, 2022
Public Version Number
5
DI Record Publish Date
August 18, 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 |