The following data is part of a premarket notification filed by Oxford Performance Materials with the FDA for Osteofab Patient Specific Cranial Device.
Device ID | K121818 |
510k Number | K121818 |
Device Name: | OSTEOFAB PATIENT SPECIFIC CRANIAL DEVICE |
Classification | Plate, Cranioplasty, Preformed, Non-alterable |
Applicant | OXFORD PERFORMANCE MATERIALS 30 S SATELLITE ROAD South Windsor, CT 06074 |
Contact | Leigh Ayres |
Correspondent | Leigh Ayres OXFORD PERFORMANCE MATERIALS 30 S 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 | 2012-06-20 |
Decision Date | 2013-02-07 |
Summary: | summary |