The following data is part of a premarket notification filed by Implex Corp. with the FDA for The Nexgen Knee System Uncemented Components.
| Device ID | K031462 |
| 510k Number | K031462 |
| Device Name: | THE NEXGEN KNEE SYSTEM UNCEMENTED COMPONENTS |
| Classification | Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, 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 | MBH |
| CFR Regulation Number | 888.3565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-08 |
| Decision Date | 2003-08-06 |
| Summary: | summary |