Cem-Ostetic Granules

Primary DI
00858418003447
Brand
Cem-Ostetic Granules
Company
BERKELEY ADVANCED BIOMATERIALS, LLC
Model
CemO-15G
Catalog number
CemO-15G
Device description
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 bone substitute shaped as granules 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 granules may be pressed into the void or into the surgical site by hand. The Cem-Ostetic granules provide void filling material that acts as a temporary support medium. The granules are not intended to provide structural support during the healing process. The implant is radio-opaque. Cem-Ostetic is biocompatible and resorbs in the body as bone ingrowth occurs.
Published
2016-04-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MQVFiller, Bone Void, Calcium Compound

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQVFiller, Bone Void, Calcium CompoundOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K030266000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K030266000CEM-OSTETIC BONE; CEMO-10G, CEMO-20G, CEMO-30G, CEMO-40G, CEMO-60G, CEM0-XXGC; CEMO-XYZ202005P, CEMO-XYZ20210P, CEMO-XYZBerkeley Advanced Biomaterials, Inc.2003-02-20MQV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858418003447PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858418003447008584180034478584180034470858418003447

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone void filling material, synthetic, bioabsorbable, non-antimicrobialA bioabsorbable, implantable device made of a synthetic material(s) intended to replace bone lost through trauma, surgery, or pathological conditions (e.g., osteoporosis); it is not dedicated to dental applications and does not include an antimicrobial agent(s). It may be made of ceramics (e.g., tricalcium phosphate or hydroxyapatite), bioactive glasses/minerals/metals (e.g., strontium), or bioabsorbable polymers. Also referred to as a graft, matrix, or void filler, it typically provides an osteoconductive scaffold that promotes bone growth, and is used to fill cystic defects, repair fractures, and/or extend autogenous bone grafts. It may have adhesive properties.

Regulatory Flags#

DUNS number
081067703
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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Primary DI, Brand, Model table
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00816125027149VitaFuse™ Bioactive Glass Graft03-0002303-000232026-07-06
00816125023660OsteoBoost Select 5ccOB-05DOB-05D2020-06-12
00816125023677OsteoBoost Select 10ccOB-10DOB-10D2020-06-12
00816125023707Tribio® DP Cotton WedgeC10 SWC05C10 SWC052020-11-13
00816125023714Tribio® DP Cotton WedgeC10 SWC06C10 SWC062020-11-13
00816125023721Tribio® DP Cotton WedgeC10 SWC07C10 SWC072020-11-13
00816125023738Tribio® DP Cotton WedgeC10 SWC08C10 SWC082020-11-13
00816125023745Tribio® DP Evans WedgeC10 SWE06C10 SWE062020-11-13
00816125023752Tribio® DP Evans WedgeC10 SWE08C10 SWE082020-11-13
00816125023769Tribio® DP Evans WedgeC10 SWE10C10 SWE102020-11-13
00816125023776Tribio® DP Evans WedgeC10 SWE12C10 SWE122020-11-13
00816125023813Bi-Ostetic Foam PuttyBF-01PBF-01P2020-10-05
00816125023820Bi-Ostetic Foam PuttyBF-02PBF-02P2020-10-05
00816125023837Bi-Ostetic Foam PuttyBF-05PBF-05P2020-10-05
00816125023844Bi-Ostetic Foam PuttyBF-10PBF-10P2020-10-05
00816125023851HA-TCP SpongeARM-TCP-10ARM-TCP-102020-11-11
00816125023868HA-TCP-Bioglass SpongeARM-TCP-BA-12ARM-TCP-BA-122020-11-11
00816125023929PURcrystals™ BioCeramic NanoCrystalsPURcrystals-10PURcrystals-102022-12-19

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