The following data is part of a premarket notification filed by Synthes Usa Products, Llc with the FDA for Synthes Hemostatic Bone Putty (hbp).
| Device ID | K103822 |
| 510k Number | K103822 |
| Device Name: | SYNTHES HEMOSTATIC BONE PUTTY (HBP) |
| Classification | Wax, Bone |
| Applicant | SYNTHES USA PRODUCTS, LLC 1230 WILSON BLVD. West Chester, PA 19380 |
| Contact | Jeffrey L Dow |
| Correspondent | Jeffrey L Dow SYNTHES USA PRODUCTS, LLC 1230 WILSON BLVD. 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 | 2010-12-30 |
| Decision Date | 2011-05-19 |
| Summary: | summary |