K2M VENADO HA/TCP Cancellous Granules - VENADO Granules Bone Graft System is a sterile - BERKELEY ADVANCED BIOMATERIALS, LLC

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.

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More Product Details

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

Product Characteristics

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 Details

Product Code

MQV

Product Code Name

Filler, Bone Void, Calcium Compound

Device Record Status

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

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BERKELEY ADVANCED BIOMATERIALS, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 178