Cem-Ostetic Putty CemO-01P

GUDID 00858418003485

Cem-Ostetic is a bio-engineered mixture of calcium-based inorganic compounds. After it is implanted, Cem-Ostetic resorbs and is later replaced by natural bone. Cem-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. Cem-Ostetic is an osteoconductive putty that is 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 putty may be shaped and pressed into the void by hand or inserted into a syringe and injected into the surgical site. The paste set in situ or ex situ provides a void filler that can augment hardware to support bone fragments during the surgical procedure. The set putty acts as a temporary support medium and is not intended to provide structural support during the healing process. The implant is radio-opaque. It is biocompatible and resorbs in the body as bone in-growth occurs.

BERKELEY ADVANCED BIOMATERIALS, LLC

Bone matrix implant, synthetic
Primary Device ID00858418003485
NIH Device Record Key15d4dde8-8b42-4d84-8ebf-a22132d06ee7
Commercial Distribution StatusIn Commercial Distribution
Brand NameCem-Ostetic Putty
Version Model NumberCemO-01P
Catalog NumberCemO-01P
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 Kittrue
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
GS100858418003485 [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 Number6
Public Version Date2019-12-23
Device Publish Date2016-04-10

On-Brand Devices [Cem-Ostetic Putty]

00858418003836Cem-Ostetic is a bio-engineered mixture of calcium-based inorganic compounds. After it is implan
00858418003485Cem-Ostetic is a bio-engineered mixture of calcium-based inorganic compounds. After it is implan
00858418003287Cem-Ostetic is a bio-engineered mixture of calcium-based inorganic compounds. After it is implan
00858418003270Cem-Ostetic is a bio-engineered mixture of calcium-based inorganic compounds. After it is implan
00858418003263Cem-Ostetic is a bio-engineered mixture of calcium-based inorganic compounds. After it is implan
00858418003027Cem-Ostetic is a bio-engineered mixture of calcium-based inorganic compounds. After it is implan

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