Duns Number:053950783
Device Description: CoRoent XL-W Trial Wndw, 60-10mm 10°Lord
Catalog Number
-
Brand Name
NuVasive
Version/Model Number
Z200221-110
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
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
K170962
Product Code
MAX
Product Code Name
Intervertebral fusion device with bone graft, lumbar
Public Device Record Key
a12a5ee6-c3c7-4094-b530-da092efe661b
Public Version Date
September 09, 2019
Public Version Number
1
DI Record Publish Date
August 30, 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 | 4207 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 38751 |
| 3 | A medical device with high risk that requires premarket approval | 84 |
| U | Unclassified | 29 |