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 |