The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Norian Srs Fast Set Putty.
| Device ID | K041842 |
| 510k Number | K041842 |
| Device Name: | NORIAN SRS FAST SET PUTTY |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Contact | Sheri L Musgnung |
| Correspondent | Sheri L Musgnung 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 | 2004-07-08 |
| Decision Date | 2004-07-23 |
| Summary: | summary |