The following data is part of a premarket notification filed by Implex Corp. with the FDA for Nexgen Trabecular Metal Tibial Cone Augments.
| Device ID | K031962 |
| 510k Number | K031962 |
| Device Name: | NEXGEN TRABECULAR METAL TIBIAL CONE AUGMENTS |
| 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 | 2003-06-25 |
| Decision Date | 2004-01-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024308558 | K031962 | 000 |
| 00889024308541 | K031962 | 000 |
| 00889024308534 | K031962 | 000 |
| 00889024308527 | K031962 | 000 |
| 00889024308510 | K031962 | 000 |
| 00889024308503 | K031962 | 000 |