The following data is part of a premarket notification filed by Biomet, Inc with the FDA for Compress And Mini Compress Anti-rotation Spindles.
| Device ID | K183553 |
| 510k Number | K183553 |
| Device Name: | Compress And Mini Compress Anti-Rotation Spindles |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented |
| Applicant | Biomet, Inc 56 East Bell Drive Warsaw, IN 46581 |
| Contact | Michael Mcburney |
| Correspondent | Michael Mcburney Biomet, Inc 56 East Bell Drive Warsaw, IN 46581 |
| Product Code | MBF |
| Subsequent Product Code | JDC |
| Subsequent Product Code | JDI |
| Subsequent Product Code | KRO |
| Subsequent Product Code | KWS |
| Subsequent Product Code | KWT |
| Subsequent Product Code | KWY |
| Subsequent Product Code | KWZ |
| Subsequent Product Code | LPH |
| Subsequent Product Code | LZO |
| Subsequent Product Code | MEH |
| CFR Regulation Number | 888.3670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-20 |
| Decision Date | 2019-01-22 |
| Summary: | summary |