The following data is part of a premarket notification filed by Zimmer, Inc with the FDA for Zimmer Guide Wire Devices.
| Device ID | K191238 |
| 510k Number | K191238 |
| Device Name: | Zimmer Guide Wire Devices |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | Zimmer, Inc PO Box 708 Warsaw, IN 46581 -0708 |
| Contact | Annette Minthorn |
| Correspondent | Annette Minthorn Zimmer, Inc PO Box 708 Warsaw, IN 46581 -0708 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-08 |
| Decision Date | 2019-07-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024581869 | K191238 | 000 |
| 00889024581845 | K191238 | 000 |
| 00889024581838 | K191238 | 000 |
| 00889024581814 | K191238 | 000 |
| 00889024581807 | K191238 | 000 |
| 00889024581791 | K191238 | 000 |
| 00889024581784 | K191238 | 000 |
| 00889024581777 | K191238 | 000 |
| 00889024581821 | K191238 | 000 |