The following data is part of a premarket notification filed by Zimmer Trabecular Metal Technology, Inc. with the FDA for Trabecular Metal Femoral Cone Augments.
| Device ID | K103517 |
| 510k Number | K103517 |
| Device Name: | TRABECULAR METAL FEMORAL CONE AUGMENTS |
| Classification | Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer |
| Applicant | ZIMMER TRABECULAR METAL TECHNOLOGY, INC. 10 POMEROY RD. Parsippany, NJ 07054 |
| Contact | Judith Rosen |
| Correspondent | Judith Rosen ZIMMER TRABECULAR METAL TECHNOLOGY, INC. 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 | 2010-11-30 |
| Decision Date | 2011-02-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024191105 | K103517 | 000 |
| 00889024308725 | K103517 | 000 |
| 00889024308718 | K103517 | 000 |
| 00889024308589 | K103517 | 000 |
| 00889024308497 | K103517 | 000 |
| 00889024308480 | K103517 | 000 |
| 00889024308473 | K103517 | 000 |
| 00889024308466 | K103517 | 000 |
| 00889024308459 | K103517 | 000 |
| 00889024308442 | K103517 | 000 |
| 00889024308435 | K103517 | 000 |
| 00889024308428 | K103517 | 000 |
| 00889024308411 | K103517 | 000 |
| 00889024308404 | K103517 | 000 |
| 00889024308398 | K103517 | 000 |
| 00889024308732 | K103517 | 000 |
| 00889024308749 | K103517 | 000 |
| 00889024308756 | K103517 | 000 |
| 00889024309395 | K103517 | 000 |
| 00889024309388 | K103517 | 000 |
| 00889024309371 | K103517 | 000 |
| 00889024309364 | K103517 | 000 |
| 00889024309340 | K103517 | 000 |
| 00889024309333 | K103517 | 000 |
| 00889024309326 | K103517 | 000 |
| 00889024308824 | K103517 | 000 |
| 00889024308817 | K103517 | 000 |
| 00889024308800 | K103517 | 000 |
| 00889024308794 | K103517 | 000 |
| 00889024308787 | K103517 | 000 |
| 00889024308770 | K103517 | 000 |
| 00889024308763 | K103517 | 000 |
| 00889024308381 | K103517 | 000 |