Duns Number:078450878
Device Description: SIGNAFUSE Bioactive Bone Graft is a bioactive bone graft substitute comprising biphasic mi SIGNAFUSE Bioactive Bone Graft is a bioactive bone graft substitute comprising biphasic mineral granules and 45S5 bioactive glass suspended in a porous type I collagen matrix. The device is provided sterile and is to be combined with autologous bone marrow aspirate prior to use to facilitate packing into bony defects. The device provides an osteoconductive scaffold that resorbs and guides host bone regeneration during the healing process.
Catalog Number
SGFS-010
Brand Name
SIGNAFUSE Bioactive Bone Graft
Version/Model Number
50X25X8 MM, 10 CC
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
K193513
Product Code
MQV
Product Code Name
Filler, Bone Void, Calcium Compound
Public Device Record Key
afa7e5a3-f627-4a21-9f3e-fa3bedac3495
Public Version Date
August 07, 2020
Public Version Number
1
DI Record Publish Date
July 30, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 16 |
| 3 | A medical device with high risk that requires premarket approval | 5 |