The following data is part of a premarket notification filed by Implex Corp. with the FDA for Trabecular Metal Femoral Cone Augments, Model 03-125-zzzz.
| Device ID | K040630 |
| 510k Number | K040630 |
| Device Name: | TRABECULAR METAL FEMORAL CONE AUGMENTS, MODEL 03-125-ZZZZ |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | IMPLEX CORP. 80 COMMERCE DR. Allendale, NJ 07401 -1600 |
| Contact | Marci Halevi |
| Correspondent | Marci Halevi IMPLEX CORP. 80 COMMERCE DR. Allendale, NJ 07401 -1600 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-10 |
| Decision Date | 2004-09-30 |