Duns Number:830350380
Device Description: HOOK 5445101 4.75 PEDICLE XS SHORT BLADE
Catalog Number
-
Brand Name
CD Horizon™ Spinal System
Version/Model Number
5445101
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
K091974
Product Code
NKB
Product Code Name
Thoracolumbosacral pedicle screw system
Public Device Record Key
484ed1a4-abbd-4d4d-9d0c-5afda2098afc
Public Version Date
September 06, 2021
Public Version Number
1
DI Record Publish Date
August 28, 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 |