FDA.reportPublic FDA data

Osteo-P™ Bone Graft Substitute

Primary DI
00811538030052
Brand
Osteo-P™ Bone Graft Substitute
Company
MOLECULAR MATRIX, INC.
Model
BGS-s25x50x3
Catalog number
BGS-s25x50x3
Device description
Osteo-P™ bone graft substitute sheet 25mm x 50mm x 3mm
Published
2018-07-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K170165000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170165000Osteo-P Bone Graft SubstituteMolecular Matrix, Inc.2017-12-29MQV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811538030052PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811538030052008115380300528115380300520811538030052

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
064845937
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811538030113Osteo-P™ Bone Graft Substitute BGS-s25x25x5BGS-s25x25x52023-07-24
00811538030120Osteo-P™ Bone Graft SubstituteBGS-s25x50x5BGS-s25x50x52023-07-24
00811538030137Osteo-P™ Bone Graft SubstituteBGS-s25x75x5BGS-s25x75x52023-07-24
00811538030144Osteo-P™ Bone Graft SubstituteBGS-s25x125x5BGS-s25x125x52023-07-24
00811538030007Osteo-P™ Bone Graft Substitute BGS-G5BGS-G52018-07-31
00811538030014Osteo-P™ Bone Graft SubstituteBGS-G10BGS-G102018-07-31
00811538030021Osteo-P™ Bone Graft SubstituteBGS-G20BGS-G202018-07-31
00811538030038Osteo-P™ Bone Graft Substitute BGS-G30BGS-G302018-07-31
00811538030045Osteo-P™ Bone Graft Substitute BGS-s25x25x3BGS-s25x25x32018-07-31
00811538030069Osteo-P™ Bone Graft SubstituteBGS-b10x6x10BGS-b10x6x102018-07-31
00811538030076Osteo-P™ Bone Graft Substitute BGS-b14x10x14BGS-b14x10x142018-07-31
00811538030083Osteo-P™ Bone Graft SubstituteBGS-s25x75x3BGS-s25x75x32018-07-31
00811538030090Osteo-P™ Bone Graft SubstituteBGS-s25x125x3BGS-s25x125x32018-07-31
00811538030106Osteo-P™ Bone Graft Substitute BGS-CL15x20BGS-CL15x202018-07-31

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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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ECURCCLM25100CERACELL Ortho Foamcurasan AGMQV2026-06-25
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ECURCCLM2550CERACELL Ortho Foamcurasan AGMQV2026-06-25
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ECURTFM1100TriForm Moldable Foamcurasan AGMQV2026-06-25
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00849777014076Union DBM, 5ccXtant Medical Holdings, Inc.MQV2026-06-24
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06429810349354Adaptos®FuseBiomendex OyMQV2026-06-24
W4184058150T0474DBX®Musculoskeletal Transplant Foundation, Inc.MQV2026-06-05
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