FDA.reportPublic FDA data

Osteo-P™ Bone Graft Substitute

Primary DI
00811538030007
Brand
Osteo-P™ Bone Graft Substitute
Company
MOLECULAR MATRIX, INC.
Model
BGS-G5
Catalog number
BGS-G5
Device description
Osteo-P™ bone graft substitute granules 5 cc
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
00811538030007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811538030007008115380300078115380300070811538030007

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
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
00811538030052Osteo-P™ Bone Graft SubstituteBGS-s25x50x3BGS-s25x50x32018-07-31
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00816125027125VitaFuse™ Bioactive Glass GraftBERKELEY ADVANCED BIOMATERIALS, LLCMQV2026-07-06
00816125027132VitaFuse™ Bioactive Glass GraftBERKELEY ADVANCED BIOMATERIALS, LLCMQV2026-07-06
00816125027149VitaFuse™ Bioactive Glass GraftBERKELEY ADVANCED BIOMATERIALS, LLCMQV2026-07-06
ECUR9920302VerteFramecurasan AGMQV2026-06-25
ECUR9920305VerteFramecurasan AGMQV2026-06-25
ECUR9920310VerteFramecurasan AGMQV2026-06-25
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ECURCCLF25250CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLF2550CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLM25100CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLM2512CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLM2525CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLM2550CERACELL Ortho Foamcurasan AGMQV2026-06-25
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
00849777014052Union DBM, 1ccXtant Medical Holdings, Inc.MQV2026-06-24
00849777014069Union DBM, 2.5ccXtant Medical Holdings, Inc.MQV2026-06-24
00849777014076Union DBM, 5ccXtant Medical Holdings, Inc.MQV2026-06-24
00849777014083Union DBM, 10ccXtant Medical Holdings, Inc.MQV2026-06-24
06429810349293Adaptos®FuseBiomendex OyMQV2026-06-24
06429810349316Adaptos®FuseBiomendex OyMQV2026-06-24
06429810349330Adaptos®FuseBiomendex OyMQV2026-06-24
06429810349354Adaptos®FuseBiomendex OyMQV2026-06-24
W4184058150T0474DBX®Musculoskeletal Transplant Foundation, Inc.MQV2026-06-05
07610221017829Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01