The following data is part of a premarket notification filed by Zimmer Trabecular with the FDA for Trabecular Metal Tibial And Femoral Cone Augments.
| Device ID | K053340 |
| 510k Number | K053340 |
| Device Name: | TRABECULAR METAL TIBIAL AND FEMORAL CONE AUGMENTS |
| Classification | Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer |
| Applicant | ZIMMER TRABECULAR 80 COMMERCE DR. Allendale, NJ 07401 |
| Contact | Marci Halevi |
| Correspondent | Marci Halevi ZIMMER TRABECULAR 80 COMMERCE DR. Allendale, NJ 07401 |
| Product Code | MBH |
| CFR Regulation Number | 888.3565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-01 |
| Decision Date | 2006-02-27 |
| Summary: | summary |