Cem-Ostetic Granules - Cem-Ostetic is a bio-engineered mixture of - BERKELEY ADVANCED BIOMATERIALS, LLC

Duns Number:081067703

Device Description: Cem-Ostetic is a bio-engineered mixture of calcium-based inorganic compounds. After it is Cem-Ostetic is a bio-engineered mixture of calcium-based inorganic compounds. After it is implanted, Cem-Ostetic resorbs and is later replaced by natural bone. Cem-Ostetic is 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.Cem-Ostetic is 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 Cem-Ostetic 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. Cem-Ostetic is biocompatible and resorbs in the body as bone ingrowth occurs.

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More Product Details

Catalog Number

CemO-20G

Brand Name

Cem-Ostetic Granules

Version/Model Number

CemO-20G

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

K030266

Product Code Details

Product Code

MQV

Product Code Name

Filler, Bone Void, Calcium Compound

Device Record Status

Public Device Record Key

c62b33c1-16f9-47a2-a9d7-e67552c02c55

Public Version Date

June 19, 2020

Public Version Number

6

DI Record Publish Date

April 10, 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