FDA.reportPublic FDA data

Porous Wedge - Evans 12 mm

Primary DI
00813909013411
Brand
Porous Wedge - Evans 12 mm
Company
NOVABONE PRODUCTS, LLC
Model
NB5612
Catalog number
NB5612
Device description
Synthetic bone void filler for orthopedic applications
Published
2025-04-09
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
MQVFiller, Bone Void, Calcium Compound

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090731000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090731000NOVABONE POROUS - SYNTHETIC BONE GRAFT SCAFFOLDNovabone Products, LLC2009-04-15MQV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813909013411PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813909013411008139090134118139090134110813909013411

GMDN Terms#

Term, Definition table
TermDefinition
Bone matrix implant, synthetic, non-antimicrobialA 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 does not include an antimicrobial agent(s). 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
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
828813290
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813909013589Wound MatrixWM0122SPWM0122SP2026-02-17
00813909013596Wound MatrixWM0123SPWM0123SP2026-02-17
00813909013602Wound MatrixWM0133SPWM0133SP2026-02-17
00813909013619Wound MatrixWM0145SPWM0145SP2026-02-17
00813909013657Wound MatrixWM1011SPWM1011SP2026-02-17
00813909013664Wound MatrixWM1022SPWM1022SP2026-02-17
00813909013671Wound MatrixWM1044SPWM1044SP2026-02-17
00813909013695Wound MatrixWM1033SPWM1033SP2026-02-17
00813909012827Wound MatrixWM0122WM01222023-12-01
00813909012834Wound MatrixWM0123WM01232023-12-01
00813909012841Wound MatrixWM0133WM01332023-12-01
00813909012858Wound MatrixWM0145WM01452023-12-01
00813909013985Putty Syringe with Cannula 2.5ccNB6502NB65022026-01-28
00813909013992Putty Syringe with Cannula 5.0ccNB6505NB65052026-01-28
00813909014005Putty Syringe with Cannula 10.0ccNB6510NB65102026-01-28
00813909013961Putty Syringe 2.5ccNB2702CTNB2702CT2026-01-09
00813909013978Putty Syringe 5.0ccNB2705CTNB2705CT2026-01-09
00813909013909Putty 2.5ccNB0602NVNB0602NV2025-12-26
00813909013916Putty 5.0ccNB0605NVNB0605NV2025-12-26
00813909013923Porous Morsels 1-2mm 5.0ccNB1805NVNB1805NV2025-12-26

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Primary DI, Brand, Company table
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00816125027149VitaFuse™ Bioactive Glass GraftBERKELEY ADVANCED BIOMATERIALS, LLCMQV2026-07-06
ECUR9920302VerteFramecurasan AGMQV2026-06-25
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ECUR9920310VerteFramecurasan AGMQV2026-06-25
ECURCCLF25100CERACELL Ortho Foamcurasan AGMQV2026-06-25
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
07610221017836Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
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