The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Zimmer Trabecular Metal Humeral Stem.
| Device ID | K041549 |
| 510k Number | K041549 |
| Device Name: | ZIMMER TRABECULAR METAL HUMERAL STEM |
| Classification | Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented |
| Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Dalene Binkley |
| Correspondent | Dalene Binkley ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Product Code | KWT |
| CFR Regulation Number | 888.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-09 |
| Decision Date | 2004-09-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024268906 | K041549 | 000 |
| 00889024268739 | K041549 | 000 |
| 00889024268722 | K041549 | 000 |
| 00889024268715 | K041549 | 000 |
| 00889024268708 | K041549 | 000 |
| 00889024268692 | K041549 | 000 |
| 00889024268685 | K041549 | 000 |
| 00889024268678 | K041549 | 000 |
| 00889024268661 | K041549 | 000 |
| 00889024268654 | K041549 | 000 |
| 00889024268647 | K041549 | 000 |
| 00889024268630 | K041549 | 000 |
| 00889024268746 | K041549 | 000 |
| 00889024268784 | K041549 | 000 |
| 00889024268890 | K041549 | 000 |
| 00889024268883 | K041549 | 000 |
| 00889024268876 | K041549 | 000 |
| 00889024268869 | K041549 | 000 |
| 00889024268852 | K041549 | 000 |
| 00889024268845 | K041549 | 000 |
| 00889024268838 | K041549 | 000 |
| 00889024268821 | K041549 | 000 |
| 00889024268814 | K041549 | 000 |
| 00889024268807 | K041549 | 000 |
| 00889024268791 | K041549 | 000 |
| 00889024268623 | K041549 | 000 |