Bi-Ostetic Cylinders BiO-DZ1040P

GUDID 00858418003812

Bi-Ostetic is a mixture with a nominal composition of 60% hydroxyapatite and 40% beta-tri-calcium phosphate. Bi-Ostetic is safe and has excellent biocompatibility. After it is implanted, the implant resorbs and is later replaced by natural bone. Bi-Ostetic is a natural choice for sparing patients the trauma of autograft harvesting. It also provides a safe alternative to human or animal cadaver bone that completely eliminates the potential for disease transmission. Bi-Ostetic is an osteoconductive bone substitute shaped as blocks (cylinders) that are 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 blocks (cylinders) may be pressed into the void or into the surgical site by hand. The Bi-Ostetic blocks (cylinders) provide void filling material that acts as a temporary support medium. The blocks (cylinders) are not intended to provide structural support during the healing process. The implant is radio-opaque. Bi-Ostetic is biocompatible and resorbs in the body as bone ingrowth occurs.

BERKELEY ADVANCED BIOMATERIALS, LLC

Bone matrix implant, synthetic
Primary Device ID00858418003812
NIH Device Record Key9600045f-bdff-4869-93b2-501add510a4c
Commercial Distribution StatusIn Commercial Distribution
Brand NameBi-Ostetic Cylinders
Version Model NumberBiO-DZ1040P
Catalog NumberBiO-DZ1040P
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
GS100858418003812 [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 StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-12-23
Device Publish Date2016-04-10

On-Brand Devices [Bi-Ostetic Cylinders]

00858418003812Bi-Ostetic is a mixture with a nominal composition of 60% hydroxyapatite and 40% beta-tri-calciu
00858418003393Bi-Ostetic is a mixture with a nominal composition of 60% hydroxyapatite and 40% beta-tri-calciu
00858418003386Bi-Ostetic is a mixture with a nominal composition of 60% hydroxyapatite and 40% beta-tri-calciu

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