Duns Number:024222105
Device Description: Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate intended to fill bony void or gaps of the extremities, posterolateral spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.
Catalog Number
102937-05
Brand Name
Trab-X SB Synthetic Bone Matrix
Version/Model Number
02-050-02-VTX
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 13, 2021
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
MQV
Product Code Name
Filler, Bone Void, Calcium Compound
Public Device Record Key
6d53cde4-34a6-4e16-8619-7e2f39cc1ed2
Public Version Date
February 15, 2021
Public Version Number
4
DI Record Publish Date
October 30, 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 |
|---|---|---|
| 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. | 35 |