Duns Number:117560455
Device Description: Pedicle Screw, Polyaxial
Catalog Number
01-PA-875-75
Brand Name
Streamline TL Spinal Fixation System
Version/Model Number
01-PA-875-75
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
K192800,K192800
Product Code
KWP
Product Code Name
APPLIANCE, FIXATION, SPINAL INTERLAMINAL
Public Device Record Key
433cb787-19fa-4f61-a45e-46fb984636c2
Public Version Date
March 22, 2022
Public Version Number
3
DI Record Publish Date
June 25, 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 | 681 |
2 | A medical device with a moderate to high risk that requires special controls. | 1571 |