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 |