OsteoBoost, 5 cc - OsteoBoost is a bio-engineered mixture of - BERKELEY ADVANCED BIOMATERIALS, LLC

Duns Number:081067703

Device Description: OsteoBoost is a bio-engineered mixture of calcium-based inorganic compounds. After it is i OsteoBoost is a bio-engineered mixture of calcium-based inorganic compounds. After it is implanted, OsteoBoost resorbs and is later replaced by natural bone. It provides a safe alternative to human or animal cadaver bone that completely eliminates the potential for disease transmission.OsteoBoost is an osteoconductive putty that is 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 putty may be shaped and pressed into the void by hand or inserted into a syringe and injected into the surgical site. The paste set in situ or ex situ provides a void filler that can augment hardware to support bone fragments during the surgical procedure. The set putty acts as a temporary support medium and is not intended to provide structural support during the healing process. The implant is radio-opaque. It is biocompatible and resorbs in the body as bone in-growth occurs.

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More Product Details

Catalog Number

OB-05P

Brand Name

OsteoBoost, 5 cc

Version/Model Number

OB-05P

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

K022622

Product Code Details

Product Code

MQV

Product Code Name

Filler, Bone Void, Calcium Compound

Device Record Status

Public Device Record Key

3e62ac3c-677e-45ec-b3d4-4e854aff7cbd

Public Version Date

June 19, 2020

Public Version Number

7

DI Record Publish Date

July 20, 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