The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Sirius Femoral Stem, Size 30a.
| Device ID | K142295 |
| 510k Number | K142295 |
| Device Name: | Sirius Femoral Stem, Size 30A |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | Biomet, Inc. 56 East Bell Drive Warsaw, IN 46581 |
| Contact | Jason Dugger |
| Correspondent | Jason Dugger Biomet, Inc. 56 East Bell Drive Warsaw, IN 46581 |
| Product Code | JDI |
| Subsequent Product Code | JDG |
| Subsequent Product Code | KWL |
| Subsequent Product Code | KWY |
| Subsequent Product Code | KWZ |
| Subsequent Product Code | LPH |
| Subsequent Product Code | LZO |
| Subsequent Product Code | LZY |
| Subsequent Product Code | MEH |
| Subsequent Product Code | OQG |
| Subsequent Product Code | OQH |
| Subsequent Product Code | OQI |
| Subsequent Product Code | PBI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-18 |
| Decision Date | 2014-09-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304681972 | K142295 | 000 |
| 00880304652125 | K142295 | 000 |
| 00880304543867 | K142295 | 000 |
| 00880304543775 | K142295 | 000 |
| 00887868261657 | K142295 | 000 |
| 00887868349669 | K142295 | 000 |
| 00887868349591 | K142295 | 000 |