The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Oss/arcos Im Total Femur Rod.
| Device ID | K152621 |
| 510k Number | K152621 |
| Device Name: | OSS/Arcos IM Total Femur Rod |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | BIOMET, INC. 56 EAST BELL DRIVE Warsaw, IN 46581 |
| Contact | Bryan Mcmahon |
| Correspondent | Bryan Mcmahon BIOMET, INC. 56 EAST BELL DRIVE Warsaw, IN 46581 |
| Product Code | JDI |
| Subsequent Product Code | JWH |
| Subsequent Product Code | KRO |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-14 |
| Decision Date | 2015-10-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304688056 | K152621 | 000 |
| 00880304687868 | K152621 | 000 |
| 00880304687851 | K152621 | 000 |
| 00880304687844 | K152621 | 000 |
| 00880304687837 | K152621 | 000 |
| 00880304683068 | K152621 | 000 |
| 00887868347771 | K152621 | 000 |
| 00887868347764 | K152621 | 000 |
| 00887868347757 | K152621 | 000 |
| 00887868347740 | K152621 | 000 |
| 00887868347733 | K152621 | 000 |
| 00887868347726 | K152621 | 000 |
| 00887868347719 | K152621 | 000 |
| 00887868347702 | K152621 | 000 |
| 00887868347696 | K152621 | 000 |
| 00887868347689 | K152621 | 000 |
| 00880304687875 | K152621 | 000 |
| 00880304687882 | K152621 | 000 |
| 00880304688049 | K152621 | 000 |
| 00880304688032 | K152621 | 000 |
| 00880304688025 | K152621 | 000 |
| 00880304688018 | K152621 | 000 |
| 00880304688001 | K152621 | 000 |
| 00880304687998 | K152621 | 000 |
| 00880304687981 | K152621 | 000 |
| 00880304687974 | K152621 | 000 |
| 00880304687967 | K152621 | 000 |
| 00880304687950 | K152621 | 000 |
| 00880304687936 | K152621 | 000 |
| 00880304687929 | K152621 | 000 |
| 00880304687912 | K152621 | 000 |
| 00880304687905 | K152621 | 000 |
| 00880304687899 | K152621 | 000 |
| 00887868347672 | K152621 | 000 |