The following data is part of a premarket notification filed by Zimmer Trabecular Metal Technology with the FDA for Trabecular Metal Tibial Cone Augments.
| Device ID | K102896 |
| 510k Number | K102896 |
| Device Name: | TRABECULAR METAL TIBIAL CONE AUGMENTS |
| Classification | Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer |
| Applicant | ZIMMER TRABECULAR METAL TECHNOLOGY 10 POMEROY RD. Parsippany, NJ 07054 |
| Contact | Kathleen Rutherford |
| Correspondent | Kathleen Rutherford ZIMMER TRABECULAR METAL TECHNOLOGY 10 POMEROY RD. Parsippany, NJ 07054 |
| Product Code | MBH |
| CFR Regulation Number | 888.3565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-30 |
| Decision Date | 2010-12-13 |
| Summary: | summary |