The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Arcomxl Polyethylene Rx90 Acetabular Liners.
| Device ID | K052255 |
| 510k Number | K052255 |
| Device Name: | ARCOMXL POLYETHYLENE RX90 ACETABULAR LINERS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | BIOMET, INC. 56 EAST BELL DR. P.O. BOX 587 Warsaw, IN 46582 |
| Contact | Allison K Koskey |
| Correspondent | Allison K Koskey BIOMET, INC. 56 EAST BELL DR. P.O. BOX 587 Warsaw, IN 46582 |
| Product Code | LPH |
| Subsequent Product Code | JDI |
| Subsequent Product Code | KWZ |
| Subsequent Product Code | LZO |
| Subsequent Product Code | MEH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-18 |
| Decision Date | 2005-11-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304651746 | K052255 | 000 |
| 00887868342967 | K052255 | 000 |
| 00887868342974 | K052255 | 000 |
| 00887868342981 | K052255 | 000 |
| 00887868342998 | K052255 | 000 |
| 00887868343001 | K052255 | 000 |
| 00887868343179 | K052255 | 000 |
| 00880304651241 | K052255 | 000 |
| 00880304651289 | K052255 | 000 |
| 00880304651296 | K052255 | 000 |
| 00880304651302 | K052255 | 000 |
| 00880304651319 | K052255 | 000 |
| 00880304651326 | K052255 | 000 |
| 00887868342929 | K052255 | 000 |