The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Arcos Trochanter Button.
| Device ID | K130063 |
| 510k Number | K130063 |
| Device Name: | ARCOS TROCHANTER BUTTON |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Becky Earl |
| Correspondent | Becky Earl BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | LPH |
| Subsequent Product Code | JDG |
| Subsequent Product Code | JDI |
| Subsequent Product Code | KWY |
| Subsequent Product Code | KWZ |
| Subsequent Product Code | LWJ |
| Subsequent Product Code | LZO |
| Subsequent Product Code | MAY |
| Subsequent Product Code | MEH |
| 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 | 2013-01-10 |
| Decision Date | 2013-04-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304539259 | K130063 | 000 |