The following data is part of a premarket notification filed by Depuy Spine, Inc. with the FDA for Healos Fx Bone Graft Substitute And Graft Mixing And Delivery System.
| Device ID | K062495 |
| 510k Number | K062495 |
| Device Name: | HEALOS FX BONE GRAFT SUBSTITUTE AND GRAFT MIXING AND DELIVERY SYSTEM |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Contact | Melanie Archer |
| Correspondent | Melanie Archer 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 | 2006-08-25 |
| Decision Date | 2006-10-13 |
| Summary: | summary |