The following data is part of a premarket notification filed by Depuy Acromed with the FDA for Symphony Graft Delivery System.
| Device ID | K003286 |
| 510k Number | K003286 |
| Device Name: | SYMPHONY GRAFT DELIVERY SYSTEM |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | DEPUY ACROMED 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Contact | Frank Maas |
| Correspondent | Frank Maas DEPUY ACROMED 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-20 |
| Decision Date | 2001-01-18 |