The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Zimmer Trabecular Metal Humeral Stem, Sizes 6mm And 8mm.
| Device ID | K050761 |
| 510k Number | K050761 |
| Device Name: | ZIMMER TRABECULAR METAL HUMERAL STEM, SIZES 6MM AND 8MM |
| Classification | Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented |
| Applicant | ZIMMER, INC. 345 E. MAIN ST. Warsaw, IN 46580 |
| Contact | Darlene Binkley |
| Correspondent | Darlene Binkley ZIMMER, INC. 345 E. MAIN ST. Warsaw, IN 46580 |
| Product Code | KWT |
| CFR Regulation Number | 888.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-24 |
| Decision Date | 2005-04-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024268777 | K050761 | 000 |
| 00889024268760 | K050761 | 000 |
| 00889024268753 | K050761 | 000 |
| 00889024268616 | K050761 | 000 |
| 00889024268609 | K050761 | 000 |
| 00889024268593 | K050761 | 000 |