The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Itst Intertrochanteric Subtrochanteric Intramedullary Femoral Nail.
| Device ID | K032367 |
| 510k Number | K032367 |
| Device Name: | ITST INTERTROCHANTERIC SUBTROCHANTERIC INTRAMEDULLARY FEMORAL NAIL |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Stephen H Mckelvey |
| Correspondent | Stephen H Mckelvey ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-01 |
| Decision Date | 2003-08-12 |
| Summary: | summary |