AlexiFuse Synthetic Foam Strip AB-3403

GUDID 00816125024797

AlexiFuse Synthetic Foam Strip is a sterile bone graft composed of purified fibrillar Type I collagen and 60% hydroxyapatite - 40% tricalcium phosphate resorbable granules. This device is safe and has excellent biocompatibility. After it is implanted, the graft resorbs and is later replaced by natural bone. AlexiFuse Synthetic Foam Strip 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 30 ml.

BERKELEY ADVANCED BIOMATERIALS, LLC

Bone matrix implant, composite
Primary Device ID00816125024797
NIH Device Record Key20fc7298-f810-4b88-a508-d8981453acac
Commercial Distribution StatusIn Commercial Distribution
Brand NameAlexiFuse Synthetic Foam Strip
Version Model NumberAB-3403
Catalog NumberAB-3403
Company DUNS081067703
Company NameBERKELEY ADVANCED BIOMATERIALS, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100816125024797 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQVFiller, Bone Void, Calcium Compound

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-12-02
Device Publish Date2024-11-22

On-Brand Devices [AlexiFuse Synthetic Foam Strip]

00816125024841AlexiFuse Synthetic Foam Strip is a sterile bone graft composed of purified fibrillar Type I col
00816125024834AlexiFuse Synthetic Foam Strip is a sterile bone graft composed of purified fibrillar Type I col
00816125024827AlexiFuse Synthetic Foam Strip is a sterile bone graft composed of purified fibrillar Type I col
00816125024810AlexiFuse Synthetic Foam Strip is a sterile bone graft composed of purified fibrillar Type I col
00816125024803AlexiFuse Synthetic Foam Strip is a sterile bone graft composed of purified fibrillar Type I col
00816125024797AlexiFuse Synthetic Foam Strip is a sterile bone graft composed of purified fibrillar Type I col
00816125024780AlexiFuse Synthetic Foam Strip is a sterile bone graft composed of purified fibrillar Type I col
00816125024773AlexiFuse Synthetic Foam Strip is a sterile bone graft composed of purified fibrillar Type I col

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