The following data is part of a premarket notification filed by Zimmer Gmbh with the FDA for Ncb Plating System.
| Device ID | K042695 |
| 510k Number | K042695 |
| Device Name: | NCB PLATING SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | ZIMMER GMBH P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Stephen H Mckelvey |
| Correspondent | Stephen H Mckelvey ZIMMER GMBH P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-30 |
| Decision Date | 2004-10-29 |
| Summary: | summary |