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 008503910072901 Montage Flowable Dispenser 008503910073063 Montage Flowable Static Mix Tips 00850391007313
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
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.

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
00850391007252Montage Settable Bone PuttyMON-BVF-16042023-11-16
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
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
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
07610221017867Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017874Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017881Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017898Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017904Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017911Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017928Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
03760191133723GlassBone GranulesNORAKERMQV2026-05-27
03760191133730GlassBone GranulesNORAKERMQV2026-05-27
03760191133747GlassBone GranulesNORAKERMQV2026-05-27
03760191133754GlassBone GranulesNORAKERMQV2026-05-27
03760191133761GlassBone GranulesNORAKERMQV2026-05-27
03760191133778GlassBone GranulesNORAKERMQV2026-05-27
03760191133785GlassBone GranulesNORAKERMQV2026-05-27
03760191134812AktiBone GranulesNORAKERMQV2026-05-27
03760191134829AktiBone GranulesNORAKERMQV2026-05-27
03760191134836AktiBone GranulesNORAKERMQV2026-05-27
03760191134843AktiBone GranulesNORAKERMQV2026-05-27
03760191134850AktiBone GranulesNORAKERMQV2026-05-27
03760191134867AktiBone GranulesNORAKERMQV2026-05-27
03760191134874AktiBone GranulesNORAKERMQV2026-05-27
03760191134881MectaBlast GranulesNORAKERMQV2026-05-27
03760191134898MectaBlast GranulesNORAKERMQV2026-05-27
03760191134904MectaBlast GranulesNORAKERMQV2026-05-27
03760191134911MectaBlast GranulesNORAKERMQV2026-05-27
03760191134928MectaBlast GranulesNORAKERMQV2026-05-27