The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Calcigen Psi Bone Graft Substitute.
| Device ID | K030178 |
| 510k Number | K030178 |
| Device Name: | CALCIGEN PSI BONE GRAFT SUBSTITUTE |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | BIOMET, INC. 56 EAST BELL DR. Warsaw, IN 46581 -0587 |
| Contact | Mary Verstynen |
| Correspondent | Mary Verstynen BIOMET, INC. 56 EAST BELL DR. Warsaw, IN 46581 -0587 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-17 |
| Decision Date | 2003-02-26 |
| Summary: | summary |