The following data is part of a premarket notification filed by Zimmer Gmbh with the FDA for Ncb Polyaxial Locking Plate System.
| Device ID | K192021 |
| 510k Number | K192021 |
| Device Name: | NCB Polyaxial Locking Plate System |
| Classification | Plate, Fixation, Bone |
| 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 | HRS |
| Subsequent Product Code | HRC |
| Subsequent Product Code | HWC |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-29 |
| Decision Date | 2019-08-22 |