Data / Medical devices / United States / Abyrx, Inc.
Abyrx, Inc.: FDA-registered device maker in Stamford, CT, United States, 39 510(k) clearances
Abyrx, Inc. is registered with the FDA (registration 3005972619) in Stamford, CT, United States. It lists 5 device types. The FDA files 39 510(k) clearances under its listings, the newest dated September 3, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3005972619
- Address
- 700 Fairfield Avenue Suite 1, Stamford, CT, United States, 06902
- Owner or operator
- ORTHOCON, INC. (9064695)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- September 21, 2006
- Registered through
- 2027
- Brand names listed
- AHBP Press, HEMASORB Apply, HEMASORB HEMOSTATIC BONE PUTTY, Hemasorb Plus Press, Hemasorb Spatula, Hemostatic Bone Putty 3 Resorbable Hemostatic Bone Putty, Montage, Montage Flowable and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation | OIS | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Cover, Burr Hole | GXR | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Filler, Bone Void, Calcium Compound | MQV | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Methyl Methacrylate For Cranioplasty | GXP | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Wax, Bone | MTJ | U | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 3, 2026 | K262769 | Permatage XT Settable Nonabsorbable Hemostatic Bone Putty (OS-PER-1001XT) | MTJ | Substantially Equivalent | Orthocon, Inc. | accessdata.fda.gov |
| June 15, 2026 | K261265 | Permatage XT Settable Bone Putty | GXP | Substantially Equivalent | Orthocon, Inc. | accessdata.fda.gov |
| June 3, 2026 | K261439 | Permatage Flowable, Settable Hemostatic Bone Paste | MTJ | Substantially Equivalent | Orthocon, Inc. | accessdata.fda.gov |
| March 16, 2026 | K253447 | Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover) | GXR | Substantially Equivalent | Orthocon, Inc. | accessdata.fda.gov |
| March 13, 2026 | K253732 | Permatage Flowable, Settable Bone Paste | GXP | Substantially Equivalent | Orthocon, Inc. | accessdata.fda.gov |
| January 2, 2026 | K253854 | MONTAGE XT Cranial Cement | GXP | Substantially Equivalent | Orthocon, Inc. | accessdata.fda.gov |
| December 5, 2024 | K243526 | MONTAGE Settable, Resorbable Bone Putty MONTAGE-QS Settable, Resorbable Bone Putty MONTAGE Flowable Settable, Resorbable Bone Paste MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty | MQV | Substantially Equivalent | Orthocon, Inc. | accessdata.fda.gov |
| November 18, 2024 | K243506 | Montage-XT Settable Bone Putty | MQV | Substantially Equivalent | Orthocon, Inc. | accessdata.fda.gov |
| September 26, 2024 | K241027 | Permatage Settable Bone Putty | GXP | Substantially Equivalent | Orthocon, Inc. | accessdata.fda.gov |
| August 21, 2024 | K233566 | Montage-XT Settable, Resorbable Bone Putty | MQV | Substantially Equivalent | Orthocon, Inc. | accessdata.fda.gov |
| July 29, 2024 | K242050 | Montage Settable Bone Putty | MQV | Substantially Equivalent | Orthocon, Inc. | accessdata.fda.gov |
| February 16, 2024 | K232771 | Montage Flowable Settable, Resorbable Bone Paste | GXP | Substantially Equivalent | Orthocon, Inc. | accessdata.fda.gov |
| October 12, 2023 | K232998 | Montage- XT Settable, Resorbable Hemostatic Bone Putty | MTJ | Substantially Equivalent | Orthocon, Inc. | accessdata.fda.gov |
| October 12, 2023 | K231475 | MONTAGE-QS Settable, Resorbable Bone Putty | GXP | Substantially Equivalent | Orthocon, Inc. | accessdata.fda.gov |
| September 1, 2023 | K231270 | Montage Flowable Settable, Resorbable Bone Paste | MQV | Substantially Equivalent | Orthocon, Inc. | accessdata.fda.gov |
| August 30, 2023 | K213418 | MONTAGE Settable, Resorbable Hemostatic Bone Putty | MTJ | Substantially Equivalent | Orthocon, Inc. | accessdata.fda.gov |
| August 25, 2023 | K231903 | Montage-QS Settable, Resorbable Bone Putty | MQV | Substantially Equivalent | Orthocon, Inc. | accessdata.fda.gov |
| July 11, 2023 | K231386 | Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste | MTJ | Substantially Equivalent | Orthocon, Inc. | accessdata.fda.gov |
| February 3, 2023 | K222063 | MONTAGE Settable, Resorbable Bone Putty | MQV | Substantially Equivalent | Orthocon, Inc. | accessdata.fda.gov |
| January 13, 2023 | K221933 | MONTAGE Settable, Resorbable Bone Putty | GXP | Substantially Equivalent | Orthocon, Inc. | accessdata.fda.gov |
| March 11, 2022 | K220315 | MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty | MTJ | Substantially Equivalent | Orthocon, Inc. | accessdata.fda.gov |
| January 19, 2021 | K202363 | HBP7 Settable Hemostatic Bone Putty | MTJ | Substantially Equivalent | Orthocon, Inc. | accessdata.fda.gov |
| March 27, 2020 | K193052 | HBP6 Settable, Resorbable Hemostatic Bone Paste | MTJ | Substantially Equivalent | Orthocon, Inc. | accessdata.fda.gov |
| July 18, 2019 | K191140 | MONTAGE-QS Settable, Resorbable Hemostatic Bone | MTJ | Substantially Equivalent | Orthocon, Inc. | accessdata.fda.gov |
| November 30, 2016 | K153317 | HEMASORBPLUS Resorbable Hemostatic Bone Putty | MTJ | Substantially Equivalent | Orthocon, Inc. | accessdata.fda.gov |
| October 15, 2015 | K152005 | MONTAGE Settable, Resorbable Hemostatic Bone Putty | MTJ | Substantially Equivalent | Orthocon, Inc. | accessdata.fda.gov |
| December 22, 2014 | K143069 | HEMASORBPLUS press Resorable Hemostatic Bone Putty | MTJ | Substantially Equivalent | Orthocon, Inc. | accessdata.fda.gov |
| October 3, 2014 | K141502 | HBP4 HARDENING, RESORBABLE HEMOSTATIC BONE PUTTY | MTJ | Substantially Equivalent | Orthocon, Inc. | accessdata.fda.gov |
| September 26, 2014 | K142339 | HEMASORB Resorbable Hemostatic Bone Putty | MTJ | Substantially Equivalent | Orthocon, LLC | accessdata.fda.gov |
| February 11, 2014 | K140117 | AHBPPRESS ABSORBABLE HEMOSTATIC BONE PUTTY | MTJ | Substantially Equivalent | Orthocon, Inc. | accessdata.fda.gov |
| April 5, 2013 | K123243 | HEMASORB BONE PUTTY 3 RESORBABLE HEMOSTATIC BONE PUTTY | MTJ | Substantially Equivalent | Orthocon, Inc. | accessdata.fda.gov |
| January 28, 2013 | K122156 | ORTHOCON ABSORBABLE HEMOSTATIC BONE PUTTY | MTJ | Substantially Equivalent | Orthocon, Inc. | accessdata.fda.gov |
| November 21, 2012 | K121953 | HEMASORB APPLY | MTJ | Substantially Equivalent | Orthocon, Inc. | accessdata.fda.gov |
| May 23, 2012 | K111575 | HEMASORB ABSORBABLE BONE HEMOSTAT MATRIX | MTJ | Substantially Equivalent | Orthocon, Inc. | accessdata.fda.gov |
| February 17, 2012 | K113627 | HEMASORB RESORBABLE HEMOSTATIC BONE PUTTY | MTJ | Substantially Equivalent | Orthocon | accessdata.fda.gov |
| February 15, 2011 | K102762 | ORTHOSTAT BONE HEMOSTAT MATRIX APPLICATOR | MTJ | Substantially Equivalent | Orthocon, Inc. | accessdata.fda.gov |
| April 28, 2009 | K091121 | ORTHOSTAT | MTJ | Substantially Equivalent | Orthocon, Inc. | accessdata.fda.gov |
| November 22, 2006 | K063330 | ORTHOCON HEMASORB RESORBABLE HEMOSTATIC BONE PUTTY | MTJ | Substantially Equivalent | Orthocon, Inc. | accessdata.fda.gov |
| August 12, 2005 | K043260 | ORTHOCON LLC ORTHOSTAT HEMOSTATIC BONE PUTTY | MTJ | Substantially Equivalent | Orthocon, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Methyl Methacrylate For Cranioplasty
- All makers of Wax, Bone
- All makers of Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation
- All makers of Filler, Bone Void, Calcium Compound
- All makers of Cover, Burr Hole
Updated September 3, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.