The following data is part of a premarket notification filed by Zimmer Gmbh with the FDA for Zimmer Natural Nail System Cephalomedullary Nails.
| Device ID | K192312 |
| 510k Number | K192312 |
| Device Name: | Zimmer Natural Nail System Cephalomedullary Nails |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | Zimmer GmbH Sulzerallee 8 Winterthur, CH 8404 |
| Contact | Annemie Rehor Kausch |
| Correspondent | Danielle Jannuzzi Madureira Zimmer GmbH Sulzerallee 8 Winterthur, CH 8404 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-26 |
| Decision Date | 2019-10-11 |
| Summary: | summary |