Duns Number:080521608
Device Description: Silica-Calcium Phosphate Composite (SCPC) is a synthetic resorbable osteoconductive bone g Silica-Calcium Phosphate Composite (SCPC) is a synthetic resorbable osteoconductive bone graft substitute composed of two phases: sodium calcium phosphate (NaCaPO4) and silica (SiO2). The two phases are sintered together in the form of solid solutions.The SCPC is in the form of porous particles in the size range 90-710 micron.The device is sterlized by Gama radiation.
Catalog Number
SCPC-1
Brand Name
Shefabone™
Version/Model Number
SCPC Granules
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
K153230
Product Code
LYC
Product Code Name
Bone Grafting Material, Synthetic
Public Device Record Key
af7e9331-40b9-44d0-8248-a440d8a444ad
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
May 18, 2017
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. | 1 |