The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Arcomxl Polyethylene Liners And Biolox Delta Heads.
| Device ID | K051411 |
| 510k Number | K051411 |
| Device Name: | ARCOMXL POLYETHYLENE LINERS AND BIOLOX DELTA HEADS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | BIOMET, INC. 56 EAST BELL DR. P.O. BOX 587 Warsaw, IN 46582 |
| Contact | Tracy Bickel Johnson |
| Correspondent | Tracy Bickel Johnson BIOMET, INC. 56 EAST BELL DR. P.O. BOX 587 Warsaw, IN 46582 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-31 |
| Decision Date | 2005-06-29 |
| Summary: | summary |