The following data is part of a premarket notification filed by Etex Corp. with the FDA for Ossifuse Bone Substitute Material.
| Device ID | K072355 |
| 510k Number | K072355 |
| Device Name: | OSSIFUSE BONE SUBSTITUTE MATERIAL |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | ETEX CORP. 38 SIDNEY ST., 3RD FLR Cambridge, MA 02139 |
| Contact | Pamela W Adams |
| Correspondent | Pamela W Adams ETEX CORP. 38 SIDNEY ST., 3RD FLR Cambridge, MA 02139 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-22 |
| Decision Date | 2007-09-26 |
| Summary: | summary |