Duns Number:602465783
Device Description: Line to Line Novel Cervical Trials, L, 9MM
Catalog Number
-
Brand Name
Novel
Version/Model Number
CI-10305-20-109
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
K081730
Product Code
ODP
Product Code Name
Intervertebral fusion device with bone graft, cervical
Public Device Record Key
0e7ccdf0-3466-4de2-a56c-ce377189c585
Public Version Date
September 28, 2020
Public Version Number
1
DI Record Publish Date
September 19, 2020
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 | 5644 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 26570 |
| U | Unclassified | 15 |