The following data is part of a premarket notification filed by Biomet Inc with the FDA for Biomet Bone Cement R.
| Device ID | K172408 |
| 510k Number | K172408 |
| Device Name: | Biomet Bone Cement R |
| Classification | Bone Cement |
| Applicant | Biomet Inc 56 East Bell Drive Warsaw, IN 46581 |
| Contact | Heidi Busz |
| Correspondent | Heidi Busz Biomet Inc 56 East Bell Drive Warsaw, IN 46581 |
| Product Code | LOD |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-09 |
| Decision Date | 2017-10-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887868214608 | K172408 | 000 |
| 00887868214578 | K172408 | 000 |