HA-TCP-Bioglass Sponge - HA-TCP-Bioglass Sponge is a bone void filler - BERKELEY ADVANCED BIOMATERIALS, LLC

Duns Number:081067703

Device Description: HA-TCP-Bioglass Sponge is a bone void filler consisting of a collagen matrix mineralized w HA-TCP-Bioglass Sponge is a bone void filler consisting of a collagen matrix mineralized with hydroxyapatite (HA) – tri-calcium phosphate (TCP) granules and 45S5 bioactive glass granules. The bovine fibrillar collagen component is biocompatible and the 45S5 glass particles are bioactive.HA-TCP-Bioglass Sponge is indicated for use in bony voids or gaps of the skeletal system (i.e. extremities, pelvis and posterolateral spine). These osseous defects are surgically created or result from traumatic injury to the bone and are not intrinsic to the stability of the bony structure. The graft resorbs and is replaced by the growth of new bone during the healing process. HA-TCP-Bioglass Sponge must be used with autogenous bone marrow aspirate and autograft in the posterolateral spine.

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More Product Details

Catalog Number

AMWS-TCP-BA-12

Brand Name

HA-TCP-Bioglass Sponge

Version/Model Number

AMWS-TCP-BA-12

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

K170917

Product Code Details

Product Code

MQV

Product Code Name

Filler, Bone Void, Calcium Compound

Device Record Status

Public Device Record Key

35b4fa23-df07-4387-b9cb-a685f92d29fc

Public Version Date

August 13, 2020

Public Version Number

1

DI Record Publish Date

August 05, 2020

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