Duns Number:117560455
Device Description: CANNULATED SCREW, POLYAXIAL
Catalog Number
05-PA-85-65
Brand Name
Streamline MIS Spinal Fixation System
Version/Model Number
05-PA-85-65
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
K192396,K192396
Product Code
MNH
Product Code Name
Orthosis, spondylolisthesis spinal fixation
Public Device Record Key
51ff69ce-a342-49d0-892c-5488afd03fa1
Public Version Date
March 22, 2022
Public Version Number
3
DI Record Publish Date
August 20, 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 |