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
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
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.

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
00850391007290Montage Flowable Settable Bone PasteMON-BVF-1501FL2023-11-16
00850391007320Montage 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