Duns Number:688211503
Device Description: Non-sterile type, Medussa Cage, Medussa-PL Solid Type, (Angle)4°, (L)25mm, (H)9mm, (W)10mm
Catalog Number
-
Brand Name
Medussa-PL Cage
Version/Model Number
MM42509C
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
K200283
Product Code
MAX
Product Code Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Public Device Record Key
f7bf69f4-0710-416f-a669-44a06302f70e
Public Version Date
July 07, 2020
Public Version Number
1
DI Record Publish Date
June 29, 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. | 10756 |