Duns Number:017921066
Device Description: 13.5mm x 70mm SI Screw - Dual Thread Washer Head
Catalog Number
GSI-SDW13570
Brand Name
Sacroiliac Joint Fusion System
Version/Model Number
1
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K191748
Product Code
OUR
Product Code Name
Sacroiliac Joint Fixation
Public Device Record Key
957ff2a8-3d9b-4438-ad39-4fac6bf769d8
Public Version Date
December 18, 2019
Public Version Number
1
DI Record Publish Date
December 10, 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 | 9 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4608 |