Duns Number:081224143
Device Description: Zygafix COMPRESSION SCREW, 6.0 x 30MM SINGLE THREAD
Catalog Number
-
Brand Name
Zyfix Spinal Facet Screw System
Version/Model Number
X076-0031
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
K123932
Product Code
MRW
Product Code Name
SYSTEM, FACET SCREW SPINAL DEVICE
Public Device Record Key
8437c2e7-e734-4c3b-bc47-56377ac5bc91
Public Version Date
June 03, 2021
Public Version Number
6
DI Record Publish Date
August 28, 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 | 1719 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3162 |
| U | Unclassified | 25 |