Duns Number:830350380
Device Description: PLATE 8638110 RIGHT SACRAL
Catalog Number
-
Brand Name
COLORADO 2™ Spinal System
Version/Model Number
8638110
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
K991031
Product Code
KWP
Product Code Name
APPLIANCE, FIXATION, SPINAL INTERLAMINAL
Public Device Record Key
5d76cab2-3d35-4e44-8927-77f1be03f09a
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 04, 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 |