Duns Number:688211503
Device Description: Medussa-PL Cage, Non-sterile type, Posterior lumbar interbody fusion cage, 3D Porous matri Medussa-PL Cage, Non-sterile type, Posterior lumbar interbody fusion cage, 3D Porous matrix, (Angle)8°, (L)25mm, (W)10mm, (H)8mm
Catalog Number
-
Brand Name
Medussa-PL Cage
Version/Model Number
MP82508C
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
bdfa775f-706f-4298-8971-ad8791063adb
Public Version Date
July 06, 2018
Public Version Number
2
DI Record Publish Date
April 11, 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 |