FDA Registration
Active
🇺🇸 United States
ABYRX, INC.
Reg #: 3005972619
·
FEI: 3005972619
·
Expires 2026
Products
4
Proprietary Names
14
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- ABYRX, INC.
- Registration Number
- 3005972619
- FEI Number
- 3005972619
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 700 Fairfield Avenue, Suite 1
- City
- Stamford
- State
- CT
- ZIP
- 06902
- Country
- US
Regulatory Submissions
- 510(k) Number
- K111575
Owner / Operator
- Firm Name
- ORTHOCON, INC.
- Operator Number
- 9064695
- Address
- 700 Fairfield Ave, Suite 1
- City
- Stamford
- State
- CT
- Postal Code
- 06902
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Wax, Bone | MTJ | Class U | Unknown | No | 2013-06-03 |
| Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation | OIS | Class 2 | Orthopedic | No | 2025-11-16 |
| Filler, Bone Void, Calcium Compound | MQV | Class 2 | Orthopedic | No | 2025-11-16 |
| Methyl Methacrylate For Cranioplasty | GXP | Class 2 | Neurology | No | 2024-10-10 |
Proprietary Names
Montage-XT
Montage Settable Bone Putty
Permatage
HEMASORB Apply
ORTHOSTAT HEMOSTATIC BONE PUTTY
HEMASORB HEMOSTATIC BONE PUTTY
Orthocon Absorbable Hemostatic Bone Putty
Montage Flowable
Hemasorb Spatula
Hemasorb Plus Press
Hemostatic Bone Putty 3 Resorbable Hemostatic Bone Putty
Montage-QS
Montage
AHBP Press
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device