The following data is part of a premarket notification filed by Implex Corp. with the FDA for The Implex Modular Elliptical Porous Acetabular Cup, Model Xx-2yy-zzzz.
| Device ID | K992409 |
| 510k Number | K992409 |
| Device Name: | THE IMPLEX MODULAR ELLIPTICAL POROUS ACETABULAR CUP, MODEL XX-2YY-ZZZZ |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | IMPLEX CORP. 80 COMMERCE DR. Allendale, NJ 07401 -1600 |
| Contact | John Schlago |
| Correspondent | John Schlago IMPLEX CORP. 80 COMMERCE DR. Allendale, NJ 07401 -1600 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-20 |
| Decision Date | 1999-10-08 |
| Summary: | summary |