Data / Medical devices / Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery
Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery (OXF): 4 FDA-registered makers in 2 countries
4 establishments in 2 countries are registered with the FDA to make Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery (product code OXF, 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 8 510(k) clearances under this code, the latest on June 20, 2025, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Product code
- OXF
- Device class
- 2
- Regulation
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| Germany | 1 |
Makers of Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery
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 |
|---|---|---|---|---|---|---|---|---|
| Acera Surgical, Inc. C/O Linda Braddon, PhD | Woodstock, GA, United States | Complaint file establishment, Specification developer | 1 | June 20, 2025 | 0 | 0 | 0 | api.fda.gov |
| W. L. Gore & Associates, Inc. | Elkton, MD, United States | Manufacturer | 1 | December 19, 2022 | 0 | 0 | 0 | api.fda.gov |
| RTI Surgical, Inc. (dba RTI Biologics, Inc.) | Alachua, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tutogen Medical GmBH | Neunkirchen am Brand Bavaria, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated June 20, 2025. 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.