FDA.reportPublic FDA data

RegenOsteo Orthopedic Beta-TCP

Primary DI
00856509002690
Brand
RegenOsteo Orthopedic Beta-TCP
Company
CYTOPHIL, INC.
Model
02-050-02-RGO
Catalog number
02-050-02-RGO
Device description
Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate intended to fill bony void or gaps of the extremities, posterolateral spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.
Published
2019-10-30
Public version status
Update
Distribution status
Not 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
MQVFiller, Bone Void, Calcium Compound

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856509002690PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856509002690008565090026908565090026900856509002690

GMDN Terms#

Term, Definition table
TermDefinition
Bone matrix implant, syntheticA sterile bioabsorbable device made of synthetic material intended to be implanted into the body to provide osteoconductive bone-tissue scaffolds, and sometimes osteovascularization, to replace bone lost through trauma, surgery, or pathological conditions (e.g., osteoporosis). It may be made of ceramics (e.g., tricalcium phosphate or hydroxyapatite), bioactive glasses/minerals/metals (e.g., strontium), or bioabsorbable polymers. It is used to fill cystic defects, repair fractures, and/or extend autogenous bone grafts and is typically provided as cancellous blocks, chips, or granules of varying sizes, or mouldable/fluid materials.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume5Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius32 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
024222105
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852108006510Regento Regenerative Scaffold02-100-03-VTX202937-10 2019-10-30
00852108006251Implant Logistics Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules04-030-01-MIL04-030-01-MIL2019-10-30
00852108006329Bank-It Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules04-030-01-PIB04-030-01-PIB2019-10-30
00852108006312Bank-It Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules04-010-01-PIB04-010-01-PIB2019-10-30
00852108006305Bank-It Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules04-005-01-PIB04-005-01-PIB2019-10-30
00852108006404Callisto Granules Beta-TCP Synthetic Bone Graft02-050-03-VEXVX-233052019-10-30
00856509002584Trab-X SB Synthetic Bone Matrix02-050-02-VTX102937-05 2019-10-30
00852108006367Callisto Granules Beta-TCP Synthetic Bone Graft02-050-02-VEXVX-120052019-10-30
00852108006381Callisto Granules Beta-TCP Synthetic Bone Graft02-200-02-VEXVX-12020 2019-10-30
00852108006411Callisto Granules Beta-TCP Synthetic Bone Graft02-100-03-VEXVX-233102019-10-30
00856509002621Trab-X SB Synthetic Bone Matrix02-050-03-VTX202937-052019-10-30
00856509002638Trab-X SB Synthetic Bone Matrix02-100-03-VTX202937-102019-10-30
00856509002706RegenOsteo Orthopedic Beta-TCP02-100-02-RGO02-100-02-RGO2019-10-30
00856509002942Zavation ZV Graft Beta-TCP Synthetic Bone Graft02-030-02-ZVG02-030-02-ZVG2019-10-30
00856509002959Zavation ZV Graft Beta-TCP Synthetic Bone Graft02-030-03-ZVG02-030-03-ZVG2019-10-30
00852108006244Implant Logistics Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules04-010-01-MIL04-010-01-MIL2019-10-30
00852108006275Implant Logistics Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules04-010-02-MIL04-010-02-MIL2019-10-30
00852108006282Implant Logistics Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules04-030-02-MIL04-030-02-MIL2019-10-30
00852108006138Implant Logistics Synthetic Biphasic Dental Bone Graft Granules03-005-02-MIL03-005-02-MIL2019-10-30
00852108006107Implant Logistics Synthetic Biphasic Dental Bone Graft Granules03-005-01-MIL03-005-01-MIL2019-10-30

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Primary DI, Brand, Company table
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00816125027149VitaFuse™ Bioactive Glass GraftBERKELEY ADVANCED BIOMATERIALS, LLCMQV2026-07-06
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ECURCCLF2550CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLM25100CERACELL Ortho Foamcurasan AGMQV2026-06-25
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ECURTFF1050TriForm Flexible Foam Stripcurasan AGMQV2026-06-25
ECURTFF1100TriForm Flexible Foam Stripcurasan AGMQV2026-06-25
ECURTFM1050TriForm Moldable Foamcurasan AGMQV2026-06-25
ECURTFM1100TriForm Moldable Foamcurasan AGMQV2026-06-25
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