The following data is part of a premarket notification filed by Biomet Manufacturing Llc with the FDA for Biomet Orthopaedic Salvage System (osstm) - Proximal Femoral & Hybrid Tibial.
| Device ID | K142814 |
| 510k Number | K142814 |
| Device Name: | Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid Tibial |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | BIOMET MANUFACTURING LLC 56 EAST BELL DR. Warsaw, IN 46581 |
| Contact | Tracy Bickel Johnson |
| Correspondent | Tracy Bickel Johnson BIOMET MANUFACTURING LLC 56 EAST BELL DR. Warsaw, IN 46581 |
| Product Code | JDI |
| Subsequent Product Code | KRO |
| Subsequent Product Code | LPH |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-29 |
| Decision Date | 2015-06-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304674462 | K142814 | 000 |
| 00880304678446 | K142814 | 000 |
| 00880304678439 | K142814 | 000 |
| 00887868519864 | K142814 | 000 |
| 00887868519857 | K142814 | 000 |