The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Periarticular Locking Plates And Screws, Series 2358 And 2359.
| Device ID | K043560 |
| 510k Number | K043560 |
| Device Name: | PERIARTICULAR LOCKING PLATES AND SCREWS, SERIES 2358 AND 2359 |
| Classification | Plate, Fixation, Bone |
| Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Laura D Williams |
| Correspondent | Laura D Williams ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-27 |
| Decision Date | 2005-01-21 |
| Summary: | summary |