The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Norian Srs Bone Void Filler.
| Device ID | K060408 |
| 510k Number | K060408 |
| Device Name: | NORIAN SRS BONE VOID FILLER |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | SYNTHES (USA) 1230 WILSON DRIVE West Chester, PA 19380 |
| Contact | Angela J Silvestri |
| Correspondent | Angela J Silvestri SYNTHES (USA) 1230 WILSON DRIVE West Chester, PA 19380 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-16 |
| Decision Date | 2006-03-21 |
| Summary: | summary |