The following data is part of a premarket notification filed by Biomet Inc. with the FDA for Refobacin Bone Cement R.
| Device ID | K171540 |
| 510k Number | K171540 |
| Device Name: | Refobacin Bone Cement R |
| Classification | Bone Cement |
| Applicant | Biomet Inc. 56 East Bell Drive Warsaw, IN 46582 |
| Contact | Heidi Busz |
| Correspondent | Heidi Busz Biomet Inc. 56 East Bell Drive Warsaw, IN 46582 |
| Product Code | LOD |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2017-05-26 |
| Decision Date | 2017-08-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304990227 | K171540 | 000 |
| 00880304990210 | K171540 | 000 |
| 00880304990203 | K171540 | 000 |
| 00880304990197 | K171540 | 000 |