The following data is part of a premarket notification filed by Etex Corporation with the FDA for Gamma-bsm; Beta-bsm; Equivabone.
| Device ID | K102812 |
| 510k Number | K102812 |
| Device Name: | GAMMA-BSM; BETA-BSM; EQUIVABONE |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | ETEX CORPORATION 38 SIDNEY STREET Cambridge, MA 02139 |
| Contact | Christopher Klaczyk |
| Correspondent | Christopher Klaczyk ETEX CORPORATION 38 SIDNEY STREET Cambridge, MA 02139 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-28 |
| Decision Date | 2010-12-03 |
| Summary: | summary |