The following data is part of a premarket notification filed by Synthes (usa) Products Llc/norian Corporation with the FDA for Synthes Hemostatic Bone Putty.
| Device ID | K113079 |
| 510k Number | K113079 |
| Device Name: | SYNTHES HEMOSTATIC BONE PUTTY |
| Classification | Wax, Bone |
| Applicant | SYNTHES (USA) PRODUCTS LLC/NORIAN CORPORATION 1230 Wilson Dr West Chester, PA 19380 |
| Contact | Jeffrey L Dow |
| Correspondent | Jeffrey L Dow SYNTHES (USA) PRODUCTS LLC/NORIAN CORPORATION 1230 Wilson Dr West Chester, PA 19380 |
| Product Code | MTJ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-17 |
| Decision Date | 2011-12-13 |
| Summary: | summary |