The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Norian Srs Bone Void Filler.
| Device ID | K011897 |
| 510k Number | K011897 |
| Device Name: | NORIAN SRS BONE VOID FILLER |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Contact | Angela J Silvestri |
| Correspondent | Angela J Silvestri SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-18 |
| Decision Date | 2001-12-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H679MXRUS20000 | K011897 | 000 |