The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Zimmer Periarticular Locking Plate System, Model 2357 & 2359.
| Device ID | K050121 |
| 510k Number | K050121 |
| Device Name: | ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM, MODEL 2357 & 2359 |
| Classification | Plate, Fixation, Bone |
| Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Noah Bartsch |
| Correspondent | Noah Bartsch 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 | 2005-01-19 |
| Decision Date | 2005-01-31 |
| Summary: | summary |