Duns Number:003489810
Device Description: Facet Fixx, Screw, Full Thread, No Washer, Ø5.0 x 45mm
Catalog Number
-
Brand Name
Facet Fixx™ Facet Screw System
Version/Model Number
14-12-5045
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
K131417
Product Code
MRW
Product Code Name
System, Facet Screw Spinal Device
Public Device Record Key
d7f7570c-2c66-4cf6-b291-8e756a18b580
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
July 23, 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 | 1102 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4259 |
| U | Unclassified | 91 |