The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Chronos-beta-tcp.
| Device ID | K053022 |
| 510k Number | K053022 |
| Device Name: | SYNTHES (USA) CHRONOS-BETA-TCP |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | SYNTHES (USA) 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Contact | Sheri L Musgnung |
| Correspondent | Sheri L Musgnung SYNTHES (USA) 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-26 |
| Decision Date | 2006-01-23 |
| Summary: | summary |