ZIMMER PERIARTICULAR SCREWS

Screw, Fixation, Bone

ZIMMER INC.

The following data is part of a premarket notification filed by Zimmer Inc. with the FDA for Zimmer Periarticular Screws.

Pre-market Notification Details

Device IDK111447
510k NumberK111447
Device Name:ZIMMER PERIARTICULAR SCREWS
ClassificationScrew, Fixation, Bone
Applicant ZIMMER INC. P.O. BOX 708 Warsaw,  IN  46581 -0708
ContactStephen H Mckelvey
CorrespondentStephen H Mckelvey
ZIMMER INC. P.O. BOX 708 Warsaw,  IN  46581 -0708
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-05-24
Decision Date2011-10-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00889024087095 K111447 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.