Data / Medical devices / Mesh, Surgical, Collagen, Large Abdominal Wall Defects
Mesh, Surgical, Collagen, Large Abdominal Wall Defects (OXK): 6 FDA-registered makers in 2 countries
6 establishments in 2 countries are registered with the FDA to make Mesh, Surgical, Collagen, Large Abdominal Wall Defects (product code OXK, Class 2, 21 CFR 878.3300). 2 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 2 510(k) clearances under this code, the latest on April 17, 2013, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- OXK
- Device class
- 2
- Regulation
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
| France | 1 |
Makers of Mesh, Surgical, Collagen, Large Abdominal Wall Defects
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Lifecell Corp | Branchburg, NJ, United States | Manufacturer | 1 | April 17, 2013 | 0 | 0 | 0 | api.fda.gov |
| Lifecell Corp. | Branchburg, NJ, United States | Complaint file establishment, Manufacturer | 1 | April 17, 2013 | 0 | 0 | 0 | api.fda.gov |
| Acell, Inc. | Columbia, MD, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Colorado Therapeutics LLC | Louisville, CO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cook Biotech, Inc. | West Lafayette, IN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sofradim Production | TREVOUX Auvergne-Rhone-Alpes, France | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated April 17, 2013. 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.