The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Periarticular Locking Plates And Screws, 2357 And 2359 Series.
Device ID | K042598 |
510k Number | K042598 |
Device Name: | PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES |
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 | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-09-23 |
Decision Date | 2004-10-29 |
Summary: | summary |