Duns Number:949461941
Device Description: The Mx-Grafter Bone Grafting System is a manual, self-contained, sterile, single use instr The Mx-Grafter Bone Grafting System is a manual, self-contained, sterile, single use instrument for the removal, harvest, and grafting of autogenous bone in surgical applications. The instrument is comprised of a plastic handle and stainless steel blade. The blade shaves bone from cortical surfaces producing short convoluted ribbons. While being cut, shavings combine with blood and flow into the handle. This graft material, an osseous coagulum, is then delivered with the handle directly to the recipient site, or to a bowl.
Catalog Number
-
Brand Name
Mx-Grafter
Version/Model Number
11302
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
-
Product Code
EMI
Product Code Name
File, Bone, Surgical
Public Device Record Key
6b5a43cb-cb6d-4009-9f8a-d91f77c64b01
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
August 03, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |