Data / Medical devices / Dura Substitute / United States
FDA-registered makers of Dura Substitute in the United States: 16 establishments
16 establishments in the United States are registered with the FDA to make Dura Substitute (product code GXQ). 14 have a 510(k) clearance or PMA approval on file and 6 have a recall event. FDA data exported November 3, 2026.
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- Device
- Dura Substitute
- Product code
- GXQ
- Country
- United States
Makers of Dura Substitute in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Collagen Matrix, Inc. | Oakland, NJ, United States | Manufacturer, Specification developer | 6 | November 18, 2025 | 0 | 0 | 0 | api.fda.gov |
| Integra LifeSciences Corporation | Princeton, NJ, United States | Complaint file establishment, Manufacturer for export, Specification developer | 6 | November 2, 2016 | 0 | 2 | 0 | api.fda.gov |
| Integra Lifesciences Corporation | Plainsboro, NJ, United States | Manufacturer, Manufacturer for export | 5 | June 15, 2012 | 0 | 2 | 0 | api.fda.gov |
| Integra Neurosciences | Anasco, PR, United States | Manufacturer | 4 | August 23, 2007 | 0 | 0 | 0 | api.fda.gov |
| Acera Surgical, Inc. C/O Linda Braddon, PhD | Woodstock, GA, United States | Complaint file establishment, Specification developer | 3 | November 27, 2017 | 0 | 0 | 0 | api.fda.gov |
| Collagen Matrix, Inc | Allendale, NJ, United States | Manufacturer | 3 | November 18, 2025 | 0 | 1 | 0 | api.fda.gov |
| Synthes (USA) Products LLC | West Chester, PA, United States | Complaint file establishment, Specification developer | 3 | January 28, 2022 | 0 | 1 | 0 | api.fda.gov |
| Cook Biotech, Inc. | West Lafayette, IN, United States | Manufacturer | 2 | October 8, 2013 | 0 | 1 | 0 | api.fda.gov |
| Integra LifeSciences Braintree Inc. | Braintree, MA, United States | Manufacturer | 1 | November 2, 2016 | 0 | 0 | 0 | api.fda.gov |
| Lemaitre Vascular, Inc. | Burlington, MA, United States | Manufacturer | 1 | June 13, 2019 | 0 | 0 | 0 | api.fda.gov |
| LeMaitre Vascular Inc. | Billerica, MA, United States | Manufacturer | 1 | June 13, 2019 | 0 | 0 | 0 | api.fda.gov |
| RTI Surgical, Inc. (dba RTI Biologics, Inc.) | Alachua, FL, United States | Specification developer | 1 | March 31, 2014 | 0 | 0 | 0 | api.fda.gov |
| SYNOVIS LIFE TECHNOLOGIES, INC. (A Subsidiary of Baxter International Inc.) | Saint Paul, MN, United States | Manufacturer | 1 | July 30, 1998 | 0 | 1 | 0 | api.fda.gov |
| W. L. Gore & Associates, Inc. | Phoenix, AZ, United States | Manufacturer | 1 | November 1, 1995 | 0 | 0 | 0 | api.fda.gov |
| Lyophilization Services Of New England, Inc. | Manchester, NH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Poly-Med, Inc. | Piedmont, SC, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 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.