FDA.reportPublic FDA data

Tribio® DP Evans Wedge

Primary DI
00816125023776
Brand
Tribio® DP Evans Wedge
Company
BERKELEY ADVANCED BIOMATERIALS, LLC
Model
C10 SWE12
Catalog number
C10 SWE12
Device description
Tribio® DP Wedge is a bone void filler consisting of 60% hydroxyapatite (HA) and 40% beta-tri-calcium phosphate (TCP). These materials have been the topic of extensive clinical studies for several decades. The device provides a scaffold around which new bone can grow. A series of surface reactions on the particles results in the formation of a calcium phosphate layer that is substantially equivalent in composition and structure to the hydroxyapatite found in bone mineral. After implantation, the device resorbs and is later replaced by natural bone.
Published
2020-11-13
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
K042636000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K042636000BIOPLUSBerkeley Advanced Biomaterials, Inc.2004-12-14MQV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816125023776PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816125023776008161250237768161250237760816125023776

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.

Regulatory Flags#

DUNS number
081067703
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
00816125027125VitaFuse™ Bioactive Glass Graft03-0002103-000212026-07-06
00816125027132VitaFuse™ Bioactive Glass Graft03-0002203-000222026-07-06
00816125027149VitaFuse™ Bioactive Glass Graft03-0002303-000232026-07-06
00816125026487ThriveSynth™ Bioactive Glass Foam PuttyTSBGP-01TSBGP-012026-05-19
00816125026494ThriveSynth™ Bioactive Glass Foam PuttyTSBGP-05TSBGP-052026-05-19
00816125026500ThriveSynth™ Bioactive Glass Foam PuttyTSBGP-10TSBGP-102026-05-19
00816125026517ThriveSynth™ Bioactive Glass Foam StripTSBGS1-50X10-01TSBGS1-50X10-012026-05-19
00816125026524ThriveSynth™ Bioactive Glass Foam StripTSBGS2-50X10-02TSBGS2-50X10-022026-05-19
00816125026531ThriveSynth™ Bioactive Glass Foam StripTSBGS1-50X10-02TSBGS1-50X10-022026-05-19
00816125026548ThriveSynth™ Bioactive Glass Foam StripTSBGS2-50X10-05TSBGS2-50X10-052026-05-19
00816125026555ThriveSynth™ Bioactive Glass Foam StripTSBGS1-50X25-06TSBGS1-50X25-062026-05-19
00816125026562ThriveSynth™ Bioactive Glass Foam StripTSBGS1-100X25-10TSBGS1-100X25-102026-05-19
00816125026579ThriveSynth™ Bioactive Glass Foam StripTSBGS1-100X25-12TSBGS1-100X25-122026-05-19
00816125026586ThriveSynth™ Bioactive Glass Foam StripTSBGS1-100X25-15TSBGS1-100X25-152026-05-19
00816125026593ThriveSynth™ Collagen Foam PuttyTSCFP-01TSCFP-012026-05-19
00816125026609ThriveSynth™ Collagen Foam PuttyTSCFP-02TSCFP-022026-05-19
00816125026616ThriveSynth™ Collagen Foam PuttyTSCFP-05TSCFP-052026-05-19
00816125026623ThriveSynth™ Collagen Foam PuttyTSCFP-10TSCFP-102026-05-19
00816125026630ThriveSynth™ Collagen Foam StripTSCFS1-50X10-01TSCFS1-50X10-012026-05-19
00816125026647ThriveSynth™ Collagen Foam StripTSCFS1-50X10-02TSCFS1-50X10-022026-05-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
07610221017843Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017850Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01