Duns Number:171513125
Device Description: Artificial Cervical Disc, 6M (6mm H x 15mm W x 12.5mm D)
Catalog Number
CDM-625 (FG 0005-01)
Brand Name
M6-C
Version/Model Number
6M
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
P170036
Product Code
MJO
Product Code Name
Prosthesis, Intervertebral Disc
Public Device Record Key
c5d9893c-9891-4c46-8b97-96162f068746
Public Version Date
April 21, 2021
Public Version Number
4
DI Record Publish Date
March 01, 2019
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 30 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 32 |
| 3 | A medical device with high risk that requires premarket approval | 11 |