The following data is part of a premarket notification filed by Zimmer Gmbh with the FDA for Affixus Natural Nail System Humeral Nail.
| Device ID | K181827 |
| 510k Number | K181827 |
| Device Name: | Affixus Natural Nail System Humeral Nail |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | Zimmer GmbH Sulzerallee 8 Winterthur, CH 8404 |
| Contact | Robert Tommasini |
| Correspondent | Danielle Jannuzzi Madureira Zimmer GmbH Sulzerallee 8 Winterthur, CH 8404 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-09 |
| Decision Date | 2018-12-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024583870 | K181827 | 000 |