The following data is part of a premarket notification filed by Oxford Performance Materials, Inc. with the FDA for Osteofab Patient Specific Cranial Device.
| Device ID | K180064 |
| 510k Number | K180064 |
| Device Name: | OsteoFab Patient Specific Cranial Device |
| Classification | Plate, Cranioplasty, Preformed, Non-alterable |
| Applicant | Oxford Performance Materials, Inc. 30 South Satellite Road South Windsor, CT 06074 |
| Contact | M. Beth Pashko |
| Correspondent | M. Beth Pashko Oxford Performance Materials, Inc. 30 South Satellite Road South Windsor, CT 06074 |
| Product Code | GXN |
| CFR Regulation Number | 882.5330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-09 |
| Decision Date | 2018-07-27 |
| Summary: | summary |