Duns Number:830350380
Device Description: SCREW XD60622-5-45 EQU PEDICULAR 5.5X45
Catalog Number
-
Brand Name
EQUATION™ Fixation System
Version/Model Number
XD60622-5-45
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 11, 2019
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
K013962
Product Code
MNH
Product Code Name
Orthosis, spondylolisthesis spinal fixation
Public Device Record Key
ebbf79bb-84fa-464d-959e-58f85ff918a2
Public Version Date
February 15, 2019
Public Version Number
4
DI Record Publish Date
July 31, 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 |