The following data is part of a premarket notification filed by Zimmer Inc. with the FDA for Zimmer Periarticular Screws.
Device ID | K111447 |
510k Number | K111447 |
Device Name: | ZIMMER PERIARTICULAR SCREWS |
Classification | Screw, Fixation, Bone |
Applicant | ZIMMER INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
Contact | Stephen H Mckelvey |
Correspondent | Stephen H Mckelvey ZIMMER INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
Product Code | HWC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-05-24 |
Decision Date | 2011-10-05 |
Summary: | summary |