The following data is part of a premarket notification filed by Depuy Spine, Inc. with the FDA for Healos Fx Injectable Bone Graft Replacement, Models 276175002, 276175005, 276175010, 276175015.
| Device ID | K081758 |
| 510k Number | K081758 |
| Device Name: | HEALOS FX INJECTABLE BONE GRAFT REPLACEMENT, MODELS 276175002, 276175005, 276175010, 276175015 |
| Classification | Filler, Bone Void, Calcium Compound |
| 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 | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-20 |
| Decision Date | 2008-09-03 |
| Summary: | summary |