Duns Number:117014636
Device Description: 10mm Insertion Screw
Catalog Number
40308-30
Brand Name
Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)
Version/Model Number
40308-30
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 17, 2021
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
-
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
K180818
Product Code
OUR
Product Code Name
Sacroiliac Joint Fixation
Public Device Record Key
7269fb01-de7a-485b-9555-4dfd4c030fca
Public Version Date
December 17, 2021
Public Version Number
4
DI Record Publish Date
June 12, 2020
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 81 |