The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Norian Xr Calcium Phosphate Bone Void Filler.
| Device ID | K023862 |
| 510k Number | K023862 |
| Device Name: | NORIAN XR CALCIUM PHOSPHATE BONE VOID FILLER |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Contact | Vikki M Hoffman |
| Correspondent | Vikki M Hoffman SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-11-20 |
| Decision Date | 2002-12-19 |
| Summary: | summary |