FDA.reportPublic FDA data

ABYRX, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30059726193005972619ABYRX, INC.1N2026-01-01700 Fairfield Avenue Suite 1 Stamford CT US 06902

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
637501096080379K243526MONTAGE Settable, Resorbable Bone Putty MONTAGE-QS Settable, Resorbable Bone Putty MONTAGE Flowable Settable, Resorbable Bone Paste MONTAGE-XT Settable, Resorbable Hemostatic Bone PuttyMQV2024-12-05
637501547240076K243506Montage-XT Settable Bone PuttyMQV2024-11-18
637501909472903K242050Montage Settable Bone PuttyMQV2024-07-29
637501223493985K241027Permatage Settable Bone PuttyGXP2024-09-26
637501071852350K233566Montage-XT Settable, Resorbable Bone PuttyMQV2024-08-21
637501513155937K232998Montage- XT Settable, Resorbable Hemostatic Bone PuttyMTJ2023-10-12
637501501925728K232771Montage Flowable Settable, Resorbable Bone PasteGXP2024-02-16
637501293153125K231903Montage-QS Settable, Resorbable Bone PuttyMQV2023-08-25
637501736709298K231475MONTAGE-QS Settable, Resorbable Bone PuttyGXP2023-10-12
637501402130395K231386Montage Flowable XRO Settable, Resorbable Hemostatic Bone PasteMTJ2023-07-11
637501255977349K231270Montage Flowable Settable, Resorbable Bone PasteMQV2023-09-01
637501608612067K222063MONTAGE Settable, Resorbable Bone PuttyMQV2023-02-03
637502072173528K221933MONTAGE Settable, Resorbable Bone PuttyGXP2023-01-13
637501571580475K220315MONTAGE-XT Settable, Resorbable Hemostatic Bone PuttyMTJ2022-03-11
637501743627207K213418MONTAGE Settable, Resorbable Hemostatic Bone PuttyMTJ2023-08-30
637501743014471K202363HBP7 Settable Hemostatic Bone PuttyMTJ2021-01-19
637501305485606K193052HBP6 Settable, Resorbable Hemostatic Bone PasteMTJ2020-03-27
637501616349321K191140MONTAGE-QS Settable, Resorbable Hemostatic BoneMTJ2019-07-18
637501953855873K153317HEMASORBPLUS Resorbable Hemostatic Bone PuttyMTJ2016-11-30
637501556420623K152005MONTAGE Settable, Resorbable Hemostatic Bone PuttyMTJ2015-10-15
637501302235511K143069HEMASORBPLUS press Resorable Hemostatic Bone PuttyMTJ2014-12-22
637501707596206K142339HEMASORB Resorbable Hemostatic Bone PuttyMTJ2014-09-26
637501188784070K141502HBP4 HARDENING, RESORBABLE HEMOSTATIC BONE PUTTYMTJ2014-10-03
637501165035720K140117AHBPPRESS ABSORBABLE HEMOSTATIC BONE PUTTYMTJ2014-02-11
637501719515454K123243HEMASORB BONE PUTTY 3 RESORBABLE HEMOSTATIC BONE PUTTYMTJ2013-04-05
637501910854218K122156ORTHOCON ABSORBABLE HEMOSTATIC BONE PUTTYMTJ2013-01-28
637501452284652K121953HEMASORB APPLYMTJ2012-11-21
637501462452161K113627HEMASORB RESORBABLE HEMOSTATIC BONE PUTTYMTJ2012-02-17
637501879405359K111575HEMASORB ABSORBABLE BONE HEMOSTAT MATRIXMTJ2012-05-23
637501931027273K102762ORTHOSTAT BONE HEMOSTAT MATRIX APPLICATORMTJ2011-02-15
637501098857094K091121ORTHOSTATMTJ2009-04-28
637501021765494K063330ORTHOCON HEMASORB RESORBABLE HEMOSTATIC BONE PUTTYMTJ2006-11-22
637501455511188K061131DBX-H HEMOSTATIC DEMINERALIZED BONE MATRIX PUTTYMBP2007-02-08
637501422688566K043260ORTHOCON LLC ORTHOSTAT HEMOSTATIC BONE PUTTYMTJ2005-08-12

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MTJ222023-10-12
MQV72024-12-05
GXP42024-09-26
MBP12007-02-08

GUDID#