Duns Number:658871135
Device Description: NuROs Absorbable Bone Graft Substitute is an implant intended to fill bony voids or gaps o NuROs Absorbable Bone Graft Substitute is an implant intended to fill bony voids or gaps of the skeletal system, i.e., extremities and pelvis. These osseous defects aresurgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. NuROs Absorbable Bone Graft Substitute is absorbed around 6 months and replaced with bone during the healing process.
Catalog Number
-
Brand Name
NuROs Bone Graft Substitute(Sterile)
Version/Model Number
BGD50
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
K140913
Product Code
MQV
Product Code Name
Filler, Bone Void, Calcium Compound
Public Device Record Key
20073f90-1949-49c1-858f-074ce5f4a094
Public Version Date
May 28, 2019
Public Version Number
1
DI Record Publish Date
May 20, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |