The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Oss Modular Stems, Oss Diaphyseal Segments.
| Device ID | K123501 |
| 510k Number | K123501 |
| Device Name: | OSS MODULAR STEMS, OSS DIAPHYSEAL SEGMENTS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Gary Baker |
| Correspondent | Gary Baker BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-13 |
| Decision Date | 2013-02-27 |
| Summary: | summary |