Synthetic Backfill Bioimplant Ø8.5 x 40mm MSBG8540

GUDID 00816125024711

The Synthetic Backfill Bioimplant is designed as a bone void filler, incorporating a collagen matrix enriched with hydroxyapatite (HA) and tri-calcium phosphate (TCP) granules, along with 45S5 bioactive glass granules. This implant utilizes biocompatible bovine fibrillar collagen and bioactive 45S5 glass particles. The granular composition includes 60 wt% HA and 40 wt% TCP, with the graft containing 20 wt% of 45S5 granules. This device serves as a scaffold to facilitate new bone growth. A sequence of surface reactions on the granules leads to the creation of a calcium phosphate layer that closely mimics the composition and structure of bone mineral hydroxyapatite. This layer, along with the HA-TCP granules, forms an osteoconductive scaffold that supports the growth of the patient’s new bone. As healing progresses, the graft material is gradually absorbed and transformed into new bone.

BERKELEY ADVANCED BIOMATERIALS, LLC

Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial
Primary Device ID00816125024711
NIH Device Record Key0f3f6172-9441-4ab0-b80e-23ecbafb909b
Commercial Distribution StatusIn Commercial Distribution
Brand NameSynthetic Backfill Bioimplant Ø8.5 x 40mm
Version Model NumberMSBG8540
Catalog NumberMSBG8540
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
GS100816125024711 [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 Date2024-05-02
Device Publish Date2024-04-24

Devices Manufactured by BERKELEY ADVANCED BIOMATERIALS, LLC

00816125024704 - Synthetic Backfill Bioimplant Ø6.5 x 40mm2024-05-02 The Synthetic Backfill Bioimplant is designed as a bone void filler, incorporating a collagen matrix enriched with hydroxyapatit
00816125024711 - Synthetic Backfill Bioimplant Ø8.5 x 40mm2024-05-02The Synthetic Backfill Bioimplant is designed as a bone void filler, incorporating a collagen matrix enriched with hydroxyapatite (HA) and tri-calcium phosphate (TCP) granules, along with 45S5 bioactive glass granules. This implant utilizes biocompatible bovine fibrillar collagen and bioactive 45S5 glass particles. The granular composition includes 60 wt% HA and 40 wt% TCP, with the graft containing 20 wt% of 45S5 granules. This device serves as a scaffold to facilitate new bone growth. A sequence of surface reactions on the granules leads to the creation of a calcium phosphate layer that closely mimics the composition and structure of bone mineral hydroxyapatite. This layer, along with the HA-TCP granules, forms an osteoconductive scaffold that supports the growth of the patient’s new bone. As healing progresses, the graft material is gradually absorbed and transformed into new bone.
00816125024711 - Synthetic Backfill Bioimplant Ø8.5 x 40mm2024-05-02 The Synthetic Backfill Bioimplant is designed as a bone void filler, incorporating a collagen matrix enriched with hydroxyapatit
00816125024353 - Putty Convenience Kit, 2.5cc2023-09-05 The Putty Convenience Kit (PCK) is a flexible polymer mat with cavities that allows the physician to mold bone putty into beads.
00816125023875 - OptiFuse BA Moldable Matrix2022-11-24 OptiFuse BA® Moldable Matrix is a bone void filler consisting of a collagen matrix mineralized with hydroxyapatite (HA) – tri
00816125023882 - OptiFuse BA Moldable Matrix2022-11-24 OptiFuse BA® Moldable Matrix is a bone void filler consisting of a collagen matrix mineralized with hydroxyapatite (HA) – tri
00816125023899 - OptiFuse BA Moldable Matrix2022-11-24 OptiFuse BA® Moldable Matrix is a bone void filler consisting of a collagen matrix mineralized with hydroxyapatite (HA) – tri
00816125023905 - OptiFuse BA Moldable Matrix2022-11-24 OptiFuse BA® Moldable Matrix is a bone void filler consisting of a collagen matrix mineralized with hydroxyapatite (HA) – tri
00816125023783 - Bi-Ostetic Bioactive Glass Foam2020-09-02 Bi-Ostetic Bioactive Glass Foam is a bone void filler consisting of a collagen matrix mineralized with hydroxyapatite (HA) – t

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