The following data is part of a premarket notification filed by Depuy Spine, Inc. with the FDA for Healos Ii Bone Graft Substitute.
| Device ID | K081432 |
| 510k Number | K081432 |
| Device Name: | HEALOS II BONE GRAFT SUBSTITUTE |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Contact | Hande Tufan |
| Correspondent | Hande Tufan DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-21 |
| Decision Date | 2008-08-29 |
| Summary: | summary |