Duns Number:315731430
Device Description: Megafix-T titanium interference Screw, 8 x 25 mm
Catalog Number
2870823T
Brand Name
Mega Fix
Version/Model Number
2870823T
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
-
Product Code
HWC
Product Code Name
Screw, Fixation, Bone
Public Device Record Key
6420b637-3b3a-4129-979a-cdffc2669121
Public Version Date
February 21, 2022
Public Version Number
3
DI Record Publish Date
October 09, 2015
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 | 3584 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4864 |
| 3 | A medical device with high risk that requires premarket approval | 18 |