The following data is part of a premarket notification filed by Etex Corp. with the FDA for Alpha-bsm, Beta-bsm, Gamma-bsm, Equivabone.
| Device ID | K091607 |
| 510k Number | K091607 |
| Device Name: | ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | ETEX CORP. 38 SIDNEY ST., 3FLR THE CLARK BLDG. Cambridge, MA 02139 |
| Contact | Christopher Klaczyk |
| Correspondent | Christopher Klaczyk ETEX CORP. 38 SIDNEY ST., 3FLR THE CLARK BLDG. 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 | 2009-06-03 |
| Decision Date | 2009-11-02 |
| Summary: | summary |