Duns Number:081067703
Device Description: VENADO Granules Bone Graft System is a sterile bone graft comprised of Bi-Ostetic (60% hyd VENADO Granules Bone Graft System is a sterile bone graft comprised of Bi-Ostetic (60% hydroxyapatite and 40% beta-tri-calcium phosphate) granules. These materials have been the topic of extensive clinical studies for a several decades. VENADO Granules are safe and have excellent biocompatibility. After it is implanted, the implant resorbs and is later replaced by natural bone. VENADO Granules are a natural choice for sparing patients the trauma of autograft harvesting. It also provides a safe alternative to human or animal cadaver bone that completely eliminates the potential for disease transmission.VENADO Granules are an osteoconductive bone substitute shaped as granules that are intended to be used to fill voids and gaps that are not intrinsic to the stability of the bone structure. These gaps or voids may be located in the extremities, spine, pelvis, or cranium. The granules may be pressed into the void or into the surgical site by hand. The VENADO Granules provide void filling material that acts as a temporary support medium. The granules are not intended to provide structural support during the healing process. The implant is radio-opaque. VENADO Granules are biocompatible and resorbs in the body as bone ingrowth occurs.
Catalog Number
4815-T6020
Brand Name
K2M VENADO HA/TCP Cancellous Granules
Version/Model Number
4815-T6020
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
K023703
Product Code
MQV
Product Code Name
Filler, Bone Void, Calcium Compound
Public Device Record Key
6a63e6ae-8fc7-4d75-a077-933a0aa4e939
Public Version Date
June 19, 2020
Public Version Number
6
DI Record Publish Date
April 08, 2016
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. | 178 |