The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Zimmer Plates And Screws (zps)-non-sterile Plates.
| Device ID | K141517 |
| 510k Number | K141517 |
| Device Name: | ZIMMER PLATES AND SCREWS (ZPS)-NON-STERILE PLATES |
| Classification | Plate, Fixation, Bone |
| Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Stephen H Mckelvey,ma, Rac |
| Correspondent | Stephen H Mckelvey,ma, Rac ZIMMER, INC. 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 | 2014-06-09 |
| Decision Date | 2014-08-13 |
| Summary: | summary |