The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Zimmer Trabecular Metal Modular Acetabular System.
| Device ID | K093561 |
| 510k Number | K093561 |
| Device Name: | ZIMMER TRABECULAR METAL MODULAR ACETABULAR SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Benjamin Curson, Cqe Rac |
| Correspondent | Benjamin Curson, Cqe Rac ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Product Code | LPH |
| Subsequent Product Code | JDI |
| Subsequent Product Code | KWZ |
| Subsequent Product Code | LZO |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-18 |
| Decision Date | 2010-04-28 |
| Summary: | summary |