The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Zimmer Plates And Screws System(zps)- Non-sterile Plates And Screws.
Device ID | K140508 |
510k Number | K140508 |
Device Name: | ZIMMER PLATES AND SCREWS SYSTEM(ZPS)- NON-STERILE PLATES AND SCREWS |
Classification | Plate, Fixation, Bone |
Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
Contact | Stephen H Mckelvey, Ma, Rac |
Correspondent | Stephen H Mckelvey, Ma, Rac ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
Product Code | HRS |
Subsequent Product Code | HTN |
Subsequent Product Code | HWC |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-02-28 |
Decision Date | 2014-08-14 |
Summary: | summary |