The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Arcom Polyethylene Acetabular Liners & Components.
| Device ID | K926107 |
| 510k Number | K926107 |
| Device Name: | ARCOM POLYETHYLENE ACETABULAR LINERS & COMPONENTS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | BIOMET, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Patricia S Beres |
| Correspondent | Patricia S Beres BIOMET, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-03 |
| Decision Date | 1993-07-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304220096 | K926107 | 000 |
| 00880304220089 | K926107 | 000 |
| 00880304220072 | K926107 | 000 |
| 00880304053052 | K926107 | 000 |
| 00880304053045 | K926107 | 000 |
| 00880304053021 | K926107 | 000 |
| 00880304044586 | K926107 | 000 |