FDA.reportPublic FDA data

Montage Settable Bone Putty

Primary DI
00850391007252
Brand
Montage Settable Bone Putty
Company
ABYRX, INC.
Model
MON-BVF-1604
Published
2023-11-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GXPMethyl Methacrylate For Cranioplasty
MQVFiller, Bone Void, Calcium Compound
OISCalcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXPMethyl Methacrylate For CranioplastyNeurology2
MQVFiller, Bone Void, Calcium CompoundOrthopedic2
OISCalcium Salt Bone Void Filler, Drillable, Non-Screw AugmentationOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850391007252PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850391007252008503910072528503910072520850391007252

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic cement, non-antimicrobialA substance designed to be used in arthroplastic and/or osteosynthetic procedures for the fixation of polymer or metallic implants to the living bone. It may also be intended for use as a filler in the case of bone pathologies (e.g., to stabilize and reinforce vertebral body structures in vertebroplasty and kyphoplasty). It is typically made from methylmethacrylate, polymethylmethacrylate (PMMA), esters of methacrylic acid or copolymers containing polymethylmethacrylate and polystyrene. This device does not contain an antimicrobial agent. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078818942
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850391007023Hemasorb 2.0 gram with SpatulaOS-2012017-01-24
00850391007139Hemasorb 1.0 gram with SpatulaOS-1012017-02-07
00850391007016Montage XT 5ccOS-MON-1001XT2025-04-07
00850391007221Montage Flowable 8ccOS-MON-1501FL2021-02-12
00850391007030Hemasorb 2.0 gram OS-201NS2016-11-16
00850391007054Hemasorb ApplyOSA-3512016-11-03
00850391007450Permatage 10ccOS-PER-20012025-05-21
00850391007443Abyrx Spatula Stand AloneOS-SPA2025-04-08
00850391007436Montage CT 7ccOS-MON-1401CT2025-04-07
00850391007245Montage Settable Bone PuttyMON-BVF-10012023-11-16
00850391007290Montage Flowable Settable Bone PasteMON-BVF-1501FL2023-11-16
00850391007306Montage Flowable Settable Bone PasteMON-BVF-1501FL2023-11-16
00850391007313Montage Flowable Settable Bone PasteMON-BVF-1501FL2023-11-16
00850391007320Montage Flowable Settable Bone PasteMON-BVF-1501FL2023-11-16
00850391007238Permatage 5ccOS-PER-10012023-10-24
00850391007269Putty Applicator GunOS-APP2023-03-24
00850391007276Putty Applicator Accessory OS-APP2023-03-24
00850391007177Montage 2cc MultipackOS-MON-16042017-04-19
00850391007337UNM Montage Flowable Tips (3x)900-MFL2022-08-25
00850391007344UNM Montage Flowable Dispenser900-MFL2022-08-25

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
W4184058150T0474DBX®Musculoskeletal Transplant Foundation, Inc.GXP2026-06-05
07610221017829Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017836Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017843Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01