STRATOFUSE Strip - STRATOFUSE is a sterile bone graft composed of - BERKELEY ADVANCED BIOMATERIALS, LLC

Duns Number:081067703

Device Description: STRATOFUSE is a sterile bone graft composed of purified fibrillar type I collagen and 60% STRATOFUSE is a sterile bone graft composed of purified fibrillar type I collagen and 60% hydroxyapatite - 40% tricalcium phosphate resorbable granules. This device, formulated as a block (strip), is safe and has excellent biocompatibility. After it is implanted, the graft resorbs and is later replaced by natural bone.STRATOFUSE is indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. The product should be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, posterolateral spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process. In weight bearing situations, the graft is to be used in conjunction with internal or external fixation devices. The fracture defect treated should not exceed 30ml.

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More Product Details

Catalog Number

BA42-501005

Brand Name

STRATOFUSE Strip

Version/Model Number

BA42-501005

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

K092046

Product Code Details

Product Code

MQV

Product Code Name

Filler, Bone Void, Calcium Compound

Device Record Status

Public Device Record Key

a6d31e92-de19-4a11-80ca-08da66626105

Public Version Date

December 23, 2019

Public Version Number

4

DI Record Publish Date

May 12, 2017

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