The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Zimmer Plates And Screws System (zps) - Non-sterile Zps.
| Device ID | K143331 |
| 510k Number | K143331 |
| Device Name: | Zimmer Plates And Screws System (ZPS) - Non-sterile ZPS |
| Classification | Plate, Fixation, Bone |
| Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Patrick Mccullagh |
| Correspondent | Stephen H Mckelvey ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Product Code | HRS |
| Subsequent Product Code | HTN |
| Subsequent Product Code | HWC |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-20 |
| Decision Date | 2015-03-04 |
| Summary: | summary |