Duns Number:688211503
Device Description: Be steriled with gamma irradiation, Posterior lumbar interbody fusion cage, 3D Porous matr Be steriled with gamma irradiation, Posterior lumbar interbody fusion cage, 3D Porous matrix, (Angle)8°, (L)25mm, (W)10mm, (H)15mm
Catalog Number
-
Brand Name
Medussa-PL Cage
Version/Model Number
MP82515CS
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K170341
Product Code
MAX
Product Code Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Public Device Record Key
ec7b1a29-fcd5-4998-9c5b-502e5ab4948d
Public Version Date
February 24, 2020
Public Version Number
2
DI Record Publish Date
October 18, 2018
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. | 10756 |