Data / Medical devices / United States / Oxford Performance Materials, Inc.
Oxford Performance Materials, Inc.: FDA-registered device maker in South Windsor, CT, United States, 3 510(k) clearances
Oxford Performance Materials, Inc. is registered with the FDA (registration 3009582362) in South Windsor, CT, United States. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated July 27, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009582362
- Address
- 30 South Satellite Road, South Windsor, CT, United States, 06074
- Owner or operator
- Oxford Performance Materials, Inc. (10043473)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer
- First device listed
- February 20, 2013
- Registered through
- 2026
- Brand names listed
- HTR-PEKK, OsteoFab Patient Specific Cranial Device, OsteoFab Patient Specific Facial Device - Optimized, Pekkton® Ivory Milling blank 95/t12mm, Pekkton® Ivory Milling blank 95/t16mm, Pekkton® Ivory Milling blank 95/t20mm, Pekkton® Ivory Milling blank 95/t25mm, Pekkton® Ivory Milling blank 95/t30mm and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction | KKY | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Material, Tooth Shade, Resin | EBF | 2 | Contract manufacturer | accessdata.fda.gov |
| Plate, Cranioplasty, Preformed, Non-Alterable | GXN | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Prosthesis, Tracheal, Expandable | JCT | 2 | Complaint file establishment, Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| July 27, 2018 | K180064 | OsteoFab Patient Specific Cranial Device | GXN | Substantially Equivalent | Oxford Performance Materials, Inc. | accessdata.fda.gov |
| July 20, 2016 | K161052 | OsteoFab Patient Specific Facial Device | KKY | Substantially Equivalent | Oxford Performance Materials, Inc. | accessdata.fda.gov |
| February 7, 2013 | K121818 | OSTEOFAB PATIENT SPECIFIC CRANIAL DEVICE | GXN | Substantially Equivalent | Oxford Performance Materials | accessdata.fda.gov |
Compare with other makers
- All makers of Material, Tooth Shade, Resin
- All makers of Prosthesis, Tracheal, Expandable
- All makers of Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
- All makers of Plate, Cranioplasty, Preformed, Non-Alterable
Updated July 27, 2018. 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.