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 |