The following data is part of a premarket notification filed by Depuy Spine, Inc. with the FDA for Modification To: Healos Bone Graft Material.
| Device ID | K043308 |
| 510k Number | K043308 |
| Device Name: | MODIFICATION TO: HEALOS BONE GRAFT MATERIAL |
| Classification | Filler, Bone Void, Calcium Compound |
| 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 | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-01 |
| Decision Date | 2005-02-16 |
| Summary: | summary |