The following data is part of a premarket notification filed by Zimmer Gmbh with the FDA for Ncb Plating System Distal Femur And Proximal Tibia.
| Device ID | K192217 |
| 510k Number | K192217 |
| Device Name: | NCB Plating System Distal Femur And Proximal Tibia |
| Classification | Plate, Fixation, Bone |
| Applicant | Zimmer GmbH Sulzerallee 8 Winterthur, CH 8404 |
| Contact | Annemie Rehor Kausch |
| Correspondent | Tiana Steinhoff Zimmer GmbH Sulzerallee 8 Winterthur, CH 8404 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-15 |
| Decision Date | 2019-09-13 |
| Summary: | summary |