Duns Number:830350380
Device Description: UCS 4.0X28 X873-028 CANN SCR TI
Catalog Number
-
Brand Name
TOWNLEY™ Transfacetpedicular Screw Fixation System
Version/Model Number
X873-028
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 17, 2021
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K003928
Product Code
MRW
Product Code Name
SYSTEM, FACET SCREW SPINAL DEVICE
Public Device Record Key
169e67a6-e3ac-4cda-8ab7-e4205dd66b2a
Public Version Date
July 07, 2022
Public Version Number
4
DI Record Publish Date
August 18, 2015
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 | 13352 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 26085 |
| 3 | A medical device with high risk that requires premarket approval | 190 |
| U | Unclassified | 75 |