Duns Number:830350380
Device Description: HOOK 859-122 NARROW BLADE SM GROOVE TI
Catalog Number
-
Brand Name
CD HORIZON® Spinal System
Version/Model Number
859-122
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
K981676
Product Code
NKB
Product Code Name
Orthosis, spinal pedicle fixation, for degenerative disc disease
Public Device Record Key
c7e46360-5157-49f4-b1ba-e5c18ddc1105
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
June 12, 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 |