Duns Number:139105691
Device Description: SI-LOK Select 12.0mm Screw, ET, 45mm
Catalog Number
-
Brand Name
SI-LOK
Version/Model Number
1202.7245
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K183119
Product Code
OUR
Product Code Name
Sacroiliac joint fixation
Public Device Record Key
c5e932dd-2bef-4435-a695-99aa50bb73ee
Public Version Date
July 22, 2019
Public Version Number
1
DI Record Publish Date
July 12, 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 | 4975 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 34645 |
| 3 | A medical device with high risk that requires premarket approval | 57 |
| U | Unclassified | 232 |