The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Itst Intertrochanteric/subtrochanteric Fixation System.
| Device ID | K143321 |
| 510k Number | K143321 |
| Device Name: | ITST Intertrochanteric/Subtrochanteric Fixation System |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Patrick Mccullagh |
| Correspondent | Stephen Mckelvey ZIMMER, INC. P.O. 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 | 2014-11-19 |
| Decision Date | 2015-05-29 |