Duns Number:830350380
Device Description: ROD 9010009115 4.75MM CCM+ 500MM HD LINE
Catalog Number
-
Brand Name
CD HORIZON® Spinal System
Version/Model Number
9010009115
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 25, 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
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
K091974
Product Code
OSH
Product Code Name
Pedicle screw spinal system, adolescent idiopathic scoliosis
Public Device Record Key
4277138b-546c-4d84-a599-bbbfd212f1f4
Public Version Date
March 31, 2022
Public Version Number
2
DI Record Publish Date
February 27, 2021
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 |