The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Zimmer Plates And Screws System (zps) Sterile 2.7mm Cortical Screws.
| Device ID | K152841 |
| 510k Number | K152841 |
| Device Name: | Zimmer Plates And Screws System (ZPS) Sterile 2.7mm Cortical Screws |
| Classification | Screw, Fixation, Bone |
| Applicant | ZIMMER, INC. P.O BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Dorothy Snyder |
| Correspondent | Dorothy Snyder ZIMMER, INC. P.O BOX 708 Warsaw, IN 46581 -0708 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-29 |
| Decision Date | 2015-11-24 |
| Summary: | summary |