Duns Number:568359710
Device Description: MULTI AXIAL PEDICLE SCREW 7.5 X 40
Catalog Number
CZ7540CT
Brand Name
VERTEFIX
Version/Model Number
CZ7540CT
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
K080075
Product Code
KWP
Product Code Name
Appliance, Fixation, Spinal Interlaminal
Public Device Record Key
d5f0987c-5d1f-48d4-a960-52263a078fe7
Public Version Date
February 03, 2020
Public Version Number
1
DI Record Publish Date
January 24, 2020
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 252 |