The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Echo Bi-metric Microplasty Line Extension.
| Device ID | K150503 |
| 510k Number | K150503 |
| Device Name: | Echo Bi-Metric Microplasty Line Extension |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | BIOMET, INC. 56 EAST BELL DRIVE Warsaw, IN 46581 |
| Contact | Amy Walriven |
| Correspondent | Amy Walriven BIOMET, INC. 56 EAST BELL DRIVE Warsaw, IN 46581 |
| Product Code | LPH |
| Subsequent Product Code | JDI |
| Subsequent Product Code | KWL |
| Subsequent Product Code | KWY |
| Subsequent Product Code | KWZ |
| Subsequent Product Code | LWJ |
| Subsequent Product Code | LZO |
| Subsequent Product Code | OQG |
| Subsequent Product Code | OQH |
| Subsequent Product Code | OQI |
| Subsequent Product Code | PBI |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-26 |
| Decision Date | 2015-03-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304698048 | K150503 | 000 |
| 00880304697898 | K150503 | 000 |
| 00880304697744 | K150503 | 000 |
| 00880304697591 | K150503 | 000 |
| 00880304697447 | K150503 | 000 |
| 00887868469572 | K150503 | 000 |
| 00887868469541 | K150503 | 000 |