Duns Number:003815548
Device Description: 50mm SAMBA Screw; The SAMBA™ Screw System is intended for fixation of sacroiliac jointdisr 50mm SAMBA Screw; The SAMBA™ Screw System is intended for fixation of sacroiliac jointdisruptions. This fixation device is to only be used in skeletally mature patients.
Catalog Number
-
Brand Name
SAMBA® Screw System
Version/Model Number
11-1109-FD6
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
K121148,K121148
Product Code
HWC
Product Code Name
Screw, Fixation, Bone
Public Device Record Key
5ef6b4e0-3317-4393-820f-c2e45f96d302
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 27, 2016
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 | 19 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 136 |