Duns Number:949024850
Catalog Number
-
Brand Name
STALIF MIDLINE
Version/Model Number
STM6035
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K141942
Product Code
OVD
Product Code Name
Intervertebral Fusion Device With Integrated Fixation, Lumbar
Public Device Record Key
e5c2fa95-5322-4006-b217-2aaac97b9067
Public Version Date
February 24, 2020
Public Version Number
5
DI Record Publish Date
March 20, 2017
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. | 788 |
3 | A medical device with high risk that requires premarket approval | 29 |