Duns Number:069472647
Device Description: HA PEEK EVOS Straight, ,13mmx9mmx 26mm , FLAT 17 ° , Narrow Nose
Catalog Number
4915-013
Brand Name
EVOS Lumbar Interbody System
Version/Model Number
4915-013
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
K150321
Product Code
MAX
Product Code Name
Intervertebral fusion device with bone graft, lumbar
Public Device Record Key
2de45e7d-84f7-461f-99fd-6c495f54cf4d
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
January 19, 2016
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. | 2310 |