UNIVERSAL CMF SYSTEM

Plate, Bone

STRYKER INSTRUMENTS

The following data is part of a premarket notification filed by Stryker Instruments with the FDA for Universal Cmf System.

Pre-market Notification Details

Device IDK022185
510k NumberK022185
Device Name:UNIVERSAL CMF SYSTEM
ClassificationPlate, Bone
Applicant STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. Kalamazoo,  MI  49087
ContactWade T Rutkoskie
CorrespondentWade T Rutkoskie
STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. Kalamazoo,  MI  49087
Product CodeJEY  
CFR Regulation Number872.4760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-07-03
Decision Date2002-12-17
Summary:summary

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