Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005972619

FEI Number

3005972619

Entity Name

ABYRX, INC.

City/State/Country

Stamford, CT, US

Establishment Address

700 Fairfield Avenue, Suite 1, Stamford, CT 06902, US

Establishment Type(s)

Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

ORTHOCON, INC. (Owner Number: 9064695)

Owner / Operator Contact Address

700 Fairfield Ave, Suite 1, Stamford, CT 06902, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K143069

PMA Number

N/A

All Registered Proprietary Names

Montage-XT Montage-XT Montage Settable Bone Putty Permatage HEMASORB Apply ORTHOSTAT HEMOSTATIC BONE PUTTY HEMASORB HEMOSTATIC BONE PUTTY Montage-XT Orthocon Absorbable Hemostatic Bone Putty Montage Flowable Hemasorb Spatula Montage Flowable Hemasorb Plus Press

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MTJ	Wax, Bone	Unknown	Class U	N/A	2013-06-03
OIS	Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation	Orthopedic	Class 2	888.3045	2025-11-16
MTJ	Wax, Bone	Unknown	Class U	N/A	2025-11-16
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2025-11-16
OIS	Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation	Orthopedic	Class 2	888.3045	2023-10-17
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2023-10-17
MTJ	Wax, Bone	Unknown	Class U	N/A	2013-06-03
OIS	Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation	Orthopedic	Class 2	888.3045	2024-10-10
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2024-10-10
MTJ	Wax, Bone	Unknown	Class U	N/A	2024-10-10
MTJ	Wax, Bone	Unknown	Class U	N/A	2022-10-14
MTJ	Wax, Bone	Unknown	Class U	N/A	2024-10-10
OIS	Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation	Orthopedic	Class 2	888.3045	2024-10-10
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2024-10-10
GXP	Methyl Methacrylate For Cranioplasty	Neurology	Class 2	882.5300	2024-10-10
MTJ	Wax, Bone	Unknown	Class U	N/A	2014-10-09
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2023-10-17
OIS	Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation	Orthopedic	Class 2	888.3045	2023-10-17
MTJ	Wax, Bone	Unknown	Class U	N/A	2013-06-03
MTJ	Wax, Bone	Unknown	Class U	N/A	2023-10-17
MTJ	Wax, Bone	Unknown	Class U	N/A	2011-06-15
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2023-10-17
OIS	Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation	Orthopedic	Class 2	888.3045	2023-10-17
MTJ	Wax, Bone	Unknown	Class U	N/A	2006-09-21
MTJ	Wax, Bone	Unknown	Class U	N/A	2014-10-09
GXP	Methyl Methacrylate For Cranioplasty	Neurology	Class 2	882.5300	2023-10-17
MTJ	Wax, Bone	Unknown	Class U	N/A	2016-11-30
MTJ	Wax, Bone	Unknown	Class U	N/A	2023-10-17
GXP	Methyl Methacrylate For Cranioplasty	Neurology	Class 2	882.5300	2023-10-17
MTJ	Wax, Bone	Unknown	Class U	N/A	2017-11-02
MTJ	Wax, Bone	Unknown	Class U	N/A	2013-05-08
MTJ	Wax, Bone	Unknown	Class U	N/A	2013-06-03
GXP	Methyl Methacrylate For Cranioplasty	Neurology	Class 2	882.5300	2024-10-10
MTJ	Wax, Bone	Unknown	Class U	N/A	2013-05-08
MTJ	Wax, Bone	Unknown	Class U	N/A	2020-10-21
MTJ	Wax, Bone	Unknown	Class U	N/A	2014-12-29

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ORTHOCON, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K180121	Cellumed Co., Ltd.	Rafugen DBM	2018-04-11
K062691	Takiron Co., Ltd.	COMPORUS	2008-04-15
K023703	Berkeley Advanced Biomaterials, Inc.	BI-OSTETIC	2003-01-30
K173933	Xenco Medical, LLC	Sorrento Bioglass Bone Graft Substitute	2018-09-13

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005972619. Last updated year: 2026. Please use registration number 3005972619 when referencing this establishment in official correspondence.