The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Trabecular Metal Tibial Cone Broach, Trabecular Metal Coupled Tibial Cone Broach.
| Device ID | K141840 |
| 510k Number | K141840 |
| Device Name: | TRABECULAR METAL TIBIAL CONE BROACH, TRABECULAR METAL COUPLED TIBIAL CONE BROACH |
| Classification | Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer |
| Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Diana Taylor |
| Correspondent | Diana Taylor ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Product Code | MBH |
| CFR Regulation Number | 888.3565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-08 |
| Decision Date | 2014-09-03 |
| Summary: | summary |