FDA.reportPublic FDA data

Montage Flowable Settable Bone Paste

Primary DI
00850391007320
Brand
Montage Flowable Settable Bone Paste
Company
ABYRX, INC.
Model
MON-BVF-1501FL
Device description
Contains 1 Montage Flowable Cartridge 00850391007290 1 Montage Flowable Dispenser 00850391007306 3 Montage Flowable Static Mix Tips 00850391007313
Published
2023-11-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850391007320PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850391007320008503910073208503910073200850391007320

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.

Regulatory Flags#

DUNS number
078818942
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850391007245Montage Settable Bone PuttyMON-BVF-10012023-11-16
00850391007252Montage Settable Bone PuttyMON-BVF-16042023-11-16
00850391007290Montage Flowable Settable Bone PasteMON-BVF-1501FL2023-11-16
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
00850391007306Montage Flowable Settable Bone PasteMON-BVF-1501FL2023-11-16
00850391007313Montage 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
00199284455788BonVie+ELUTE , INC.MQV2025-08-13
00643169964938GRAFTON™ DBMMEDTRONIC SOFAMOR DANEK, INC.MQV2024-12-05
00763000140502PROGENIX™ PUTTY and PROGENIX™ PLUSMEDTRONIC SOFAMOR DANEK, INC.MQV2021-03-12
00763000140519PROGENIX™ PUTTY and PROGENIX™ PLUSMEDTRONIC SOFAMOR DANEK, INC.MQV2021-03-12
00763000140526PROGENIX™ PUTTY and PROGENIX™ PLUSMEDTRONIC SOFAMOR DANEK, INC.MQV2021-03-12
00763000140533PROGENIX™ PUTTY and PROGENIX™ PLUSMEDTRONIC SOFAMOR DANEK, INC.MQV2021-03-12
00085412630731ALTAPOREApatech LtdMQV2020-11-05
00085412678146ALTAPOREApatech LtdMQV2020-11-05
00085412654362ALTAPOREApatech LtdMQV2019-12-11
00085412654379ALTAPOREApatech LtdMQV2019-12-11
00085412654386ALTAPOREApatech LtdMQV2019-12-11
00085412654393ALTAPOREApatech LtdMQV2019-12-11
00613994247612PROGENIX® PUTTY and PROGENIX® PLUSMEDTRONIC SOFAMOR DANEK, INC.MQV2019-03-29
00643169965089GRAFTON® DBMMEDTRONIC SOFAMOR DANEK, INC.MQV2019-02-07
00613994512758MASTERGRAFT® Mini GranulesMEDTRONIC SOFAMOR DANEK, INC.MQV2018-11-18
00613994512765MASTERGRAFT® Mini GranulesMEDTRONIC SOFAMOR DANEK, INC.MQV2018-11-18
00613994512772MASTERGRAFT® Mini GranulesMEDTRONIC SOFAMOR DANEK, INC.MQV2018-11-18
00613994512789MASTERGRAFT® Mini GranulesMEDTRONIC SOFAMOR DANEK, INC.MQV2018-11-18
00613994512796MASTERGRAFT® Mini GranulesMEDTRONIC SOFAMOR DANEK, INC.MQV2018-11-18
00613994512802MASTERGRAFT® Mini GranulesMEDTRONIC SOFAMOR DANEK, INC.MQV2018-11-18
00613994512819MASTERGRAFT® Mini GranulesMEDTRONIC SOFAMOR DANEK, INC.MQV2018-11-18
00613994512826MASTERGRAFT® Mini GranulesMEDTRONIC SOFAMOR DANEK, INC.MQV2018-11-18
00643169965065GRAFTON® DBMMEDTRONIC SOFAMOR DANEK, INC.MQV2018-01-26
00643169141858MAGNIFUSE® Bone GraftMEDTRONIC SOFAMOR DANEK, INC.MQV2017-07-23
00643169719361MASTERGRAFT® StripMEDTRONIC SOFAMOR DANEK, INC.MQV2016-09-09
00643169719378MASTERGRAFT® StripMEDTRONIC SOFAMOR DANEK, INC.MQV2016-09-09
00643169719385MASTERGRAFT® StripMEDTRONIC SOFAMOR DANEK, INC.MQV2016-09-09
00643169218093PLEXUR P®MEDTRONIC SOFAMOR DANEK, INC.MQV2016-04-02
00643169218116PLEXUR P®MEDTRONIC SOFAMOR DANEK, INC.MQV2016-04-02
00643169218130PLEXUR P®MEDTRONIC SOFAMOR DANEK, INC.MQV2016-04-02