FDA.reportPublic FDA data

OsteonIII

Primary DI
08809324768175
Brand
OsteonIII
Company
GENOSS CO., Ltd.
Model
3G1020050
Catalog number
3G1020050
Device description
Bone grafting material, synthetic
Published
2018-07-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LYCBone grafting material, synthetic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYCBone Grafting Material, SyntheticDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153676000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153676000OSTEON IIIGenoss Co., Ltd.2016-09-14LYC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809324768175PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809324768175088093247681758809324768175

GMDN Terms#

Term, Definition table
TermDefinition
Synthetic bone graftAn artificial bone substitute used for structural bone replacement typically when bone is lost due to disease (e.g., osteoporosis) or injury. It consists mainly of porous and mesh ceramic materials that provide a framework for bone growth, or harvested sea coral that serves as an additive, extender, or provides a framework for bone growth. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume0.5Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature1 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method
Radiation Sterilization

Regulatory Flags#

DUNS number
690083006
Device count
1
DM exempt
true
Lot or batch
true
Serial number
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800026544722Implant Guide Kit GIGK2024-07-19
08800026544739Implant Guide Kit GGD26292024-07-19
08800026544746Implant Guide Kit GGD26352024-07-19
08800026544753Implant Guide Kit GMG22024-07-19
08800026544760Implant Guide Kit GSP052024-07-19
08800026544777Implant Guide Kit GSP072024-07-19
08800026544784Implant Guide Kit GSP092024-07-19
08800026544791Implant Guide Kit GSP112024-07-19
08800026544807Implant Guide Kit GGP04052024-07-19
08800026544814Implant Guide Kit GGP06072024-07-19
08800026544821Implant Guide Kit GGP08092024-07-19
08800026544838Implant Guide Kit GGP10112024-07-19
08800026501558GENOSS Inflator B30GBI-B302024-06-18
08800026501565GENOSS Inflator B30GBI-302024-06-18
08800026507598GENOSS Inflator B30GBI-B30S2024-06-18
08800026507611GENOSS Inflator B40 GBI-B40V2024-06-18
08800026507635GENOSS Inflator B40 GBI-B40VS2024-06-18
08800026512752GENOSS Inflator B40 GBI-B40S2024-06-18
08800026530329GENOSS Inflator B30GBI-B302024-06-18
08809324765433GENOSS Inflator B30GBI-30V2024-06-18

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Primary DI, Brand, Company table
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03700501800488MBCP+®BIOMATLANTELYC2026-06-29
03700501800495MBCP+®BIOMATLANTELYC2026-06-29
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03700501800709MBCP+®BIOMATLANTELYC2026-06-29
03700501800716MBCP+®BIOMATLANTELYC2026-06-29
00813954028767Gibson Healthcare AlloplastCOLLAGEN MATRIX, INC.LYC2026-05-26
00813954028774Gibson Healthcare AlloplastCOLLAGEN MATRIX, INC.LYC2026-05-26
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07290014838116Bond ApatiteAUGMA BIOMATERIALS LTDLYC2026-02-04
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072900148381783D Bond+AUGMA BIOMATERIALS LTDLYC2026-02-04
072900148381853D Bond+AUGMA BIOMATERIALS LTDLYC2026-02-04
072900148381923D Bond+AUGMA BIOMATERIALS LTDLYC2026-02-04
072900148382083D BondAUGMA BIOMATERIALS LTDLYC2026-02-04
072900148382153D BondAUGMA BIOMATERIALS LTDLYC2026-02-04
07290014838130Bond ApatiteAUGMA BIOMATERIALS LTDLYC2026-01-15
00813954026787SynOss PlugCOLLAGEN MATRIX, INC.LYC2025-09-05
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00813909010335Dental Porous Morsels 2x1.5gNOVABONE PRODUCTS, LLCLYC2025-07-17
00813909010328Dental Porous Morsels 2x0.5gNOVABONE PRODUCTS, LLCLYC2025-07-17
00813954027128PLENA PLUGCOLLAGEN MATRIX, INC.LYC2025-07-16
00813954027135PLENA PLUGCOLLAGEN MATRIX, INC.LYC2025-07-16
00813954027050TBS Bone PlugCOLLAGEN MATRIX, INC.LYC2025-05-19
00813954027067TBS Bone PlugCOLLAGEN MATRIX, INC.LYC2025-05-19