The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Stageone Select Cement Spacer Molds For Temporary Hip Replacement.
| Device ID | K161166 |
| 510k Number | K161166 |
| Device Name: | StageOne Select Cement Spacer Molds For Temporary Hip Replacement |
| Classification | Bone Cement, Antibiotic |
| Applicant | BIOMET, INC. 56 EAST BELL DRIVE Warsaw, IN 46581 |
| Contact | Carmen Albany |
| Correspondent | Heidi Busz BIOMET, INC. 56 EAST BELL DRIVE Warsaw, IN 46581 |
| Product Code | MBB |
| Subsequent Product Code | KWL |
| Subsequent Product Code | KWY |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2016-04-26 |
| Decision Date | 2016-09-08 |
| Summary: | summary |