Duns Number:073670228
Device Description: The M-Fix is designed to provide reduction and stabilization of the acromioclavicular join The M-Fix is designed to provide reduction and stabilization of the acromioclavicular joint while providing a simpler, streamlined surgical technique.
Catalog Number
-
Brand Name
M-Fix 4mm
Version/Model Number
FG3004
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
K153211
Product Code
HTN
Product Code Name
Washer, Bolt Nut
Public Device Record Key
c241cdf8-be0d-480b-ba45-7b7c2f281481
Public Version Date
July 19, 2018
Public Version Number
1
DI Record Publish Date
June 18, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |