Duns Number:139105691
Device Description: COALITION MIS Spacer, 15 x 18, 12°, 11mm
Catalog Number
-
Brand Name
COALITION MIS
Version/Model Number
3136.4611
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K151939
Product Code
OVE
Product Code Name
Intervertebral fusion device with integrated fixation, cervical
Public Device Record Key
1a29ab62-d6a2-420f-ba00-adb294e1cc4d
Public Version Date
February 24, 2020
Public Version Number
4
DI Record Publish Date
February 27, 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 | 4975 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 34645 |
| 3 | A medical device with high risk that requires premarket approval | 57 |
| U | Unclassified | 232 |