Duns Number:080300717
Device Description: 5.5/6.0mm, Non-mod Closed Tulip 7.1mm- Iliac Shank - 9.5mm x 120mm
Catalog Number
LS-N6CR9520
Brand Name
LineSider
Version/Model Number
LS-N6CR9520
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
K203367
Product Code
KWP
Product Code Name
Appliance, Fixation, Spinal Interlaminal
Public Device Record Key
fd2bfef7-71bb-4fef-b6d7-9f3891474076
Public Version Date
May 13, 2022
Public Version Number
2
DI Record Publish Date
February 16, 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 | 787 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1255 |