Duns Number:488227125
Device Description: Cervical Interbody Fusion Device TiPEEK “Dome shaped” 15x18x9 L5°- Ti markers
Catalog Number
-
Brand Name
Mecta-C Ti mark
Version/Model Number
03.28.330
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
K172587
Product Code
ODP
Product Code Name
Intervertebral Fusion Device With Bone Graft, Cervical
Public Device Record Key
3ec02490-c21c-4aa9-b737-acdcc24c49f0
Public Version Date
November 02, 2021
Public Version Number
1
DI Record Publish Date
October 25, 2021
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 | 8200 |
2 | A medical device with a moderate to high risk that requires special controls. | 9084 |