The following data is part of a premarket notification filed by Etex Corp. with the FDA for Equivabone Osteoinductive Bone Graft Substitute.
| Device ID | K090855 |
| 510k Number | K090855 |
| Device Name: | EQUIVABONE OSTEOINDUCTIVE BONE GRAFT SUBSTITUTE |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | ETEX CORP. 38 SIDNEY ST. Cambridge, MA 02139 |
| Contact | Christopher Klaczyk |
| Correspondent | Christopher Klaczyk ETEX CORP. 38 SIDNEY ST. Cambridge, MA 02139 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-30 |
| Decision Date | 2009-09-18 |
| Summary: | summary |