The following data is part of a premarket notification filed by Depuy Spine, Inc. with the FDA for Healos Dental Bone Graft Substitute (also Called Healos Or Healos Ii) Model 6008, 6025.
| Device ID | K093390 |
| 510k Number | K093390 |
| Device Name: | HEALOS DENTAL BONE GRAFT SUBSTITUTE (ALSO CALLED HEALOS OR HEALOS II) MODEL 6008, 6025 |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Contact | Sharon Starowicz |
| Correspondent | Sharon Starowicz DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-29 |
| Decision Date | 2010-05-25 |
| Summary: | summary |