The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Norian Crs Bone Cement.
| Device ID | K060445 |
| 510k Number | K060445 |
| Device Name: | NORIAN CRS BONE CEMENT |
| Classification | Methyl Methacrylate For Cranioplasty |
| Applicant | SYNTHES (USA) 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Contact | Angela Silvestri |
| Correspondent | Angela Silvestri SYNTHES (USA) 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Product Code | GXP |
| CFR Regulation Number | 882.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-21 |
| Decision Date | 2006-04-13 |
| Summary: | summary |