Duns Number:807613393
Device Description: Tactoset is a synthetic, injectable, settable osteoconductive calcium phosphate bone graft Tactoset is a synthetic, injectable, settable osteoconductive calcium phosphate bone graft substitute material.
Catalog Number
-
Brand Name
Tactoset
Version/Model Number
6000041
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
K173008
Product Code
MQV
Product Code Name
Filler, Bone Void, Calcium Compound
Public Device Record Key
d09f96d6-abe2-4678-b01e-7c479cc8cb09
Public Version Date
June 19, 2020
Public Version Number
2
DI Record Publish Date
October 15, 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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |
| 3 | A medical device with high risk that requires premarket approval | 15 |