The following data is part of a premarket notification filed by Biomet Orthopedics, Inc. with the FDA for Calcigen-s Bone Void Filer.
| Device ID | K013790 |
| 510k Number | K013790 |
| Device Name: | CALCIGEN-S BONE VOID FILER |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | BIOMET ORTHOPEDICS, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Patricia S Beres |
| Correspondent | Patricia S Beres BIOMET ORTHOPEDICS, INC. P.O. BOX 587 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 | 2001-11-14 |
| Decision Date | 2002-06-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887868284854 | K013790 | 000 |
| 00887868284847 | K013790 | 000 |
| 00887868284830 | K013790 | 000 |