The following data is part of a premarket notification filed by Synthes with the FDA for Chronos Tricalcium Prosphate (chronos Tcp).
| Device ID | K013072 |
| 510k Number | K013072 |
| Device Name: | CHRONOS TRICALCIUM PROSPHATE (CHRONOS TCP) |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | SYNTHES 1690 RUSSELL RD. Paoli, PA 19301 |
| Contact | Thomas M Marguire |
| Correspondent | Thomas M Marguire SYNTHES 1690 RUSSELL RD. Paoli, PA 19301 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-13 |
| Decision Date | 2002-11-26 |
| Summary: | summary |