FDA.reportPublic FDA data

OsteoMatrix

Primary DI
00852371006088
Brand
OsteoMatrix
Company
BIOSTRUCTURES, LLC
Model
OMCS10
Catalog number
OMCS10
Device description
Mineralized Collagen Scaffold
Published
2015-11-09
Public version status
Update
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
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
00852371006088PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852371006088008523710060888523710060880852371006088

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
Length50Millimeter
Width15Millimeter

Sterilization Methods#

Method table
Method
Radiation Sterilization

Regulatory Flags#

DUNS number
827042487
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852371006095OsteoMatrixOMCS05OMCS052015-11-09
00852371006101SilhouetteSIL-180SIL-1802015-12-21
00852371006118SilhouetteSIL-090SIL-0902015-12-21
00852371006002SignafuseSGF-150SGF-1502015-12-21
00852371006019SignafuseSGF-075SGF-0752015-12-21
00852371006026SignafuseSGF-037SGF-0372015-12-21
00852371006033OsteofuseOF001OF0012015-11-16

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Primary DI, Brand, Company table
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ECURCCLF2550CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLM25100CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLM2512CERACELL Ortho Foamcurasan AGMQV2026-06-25
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ECURCCLM2550CERACELL Ortho Foamcurasan AGMQV2026-06-25
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