Duns Number:183641617
Device Description: Centerline Gx Ø5.5 Tap, Awl Tip - Non-Cannulated
Catalog Number
176-046
Brand Name
Centerline Thoracolumbar Spinal System
Version/Model Number
176-046
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
K151196
Product Code
NKB
Product Code Name
Thoracolumbosacral pedicle screw system
Public Device Record Key
435e1648-afdc-4c55-82b4-685f9a6e1131
Public Version Date
November 15, 2019
Public Version Number
1
DI Record Publish Date
November 07, 2019
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 | 315 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 9180 |
| U | Unclassified | 47 |