SYNTHES (USA) DISTAL FEMUR PLATE (DFP) SYSTEM

Screw, Fixation, Bone

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Distal Femur Plate (dfp) System.

Pre-market Notification Details

Device IDK982222
510k NumberK982222
Device Name:SYNTHES (USA) DISTAL FEMUR PLATE (DFP) SYSTEM
ClassificationScrew, Fixation, Bone
Applicant SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli,  PA  19301 -1222
ContactSheri L Musgnung
CorrespondentSheri L Musgnung
SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli,  PA  19301 -1222
Product CodeHWC  
Subsequent Product CodeHRS
Subsequent Product CodeHTY
Subsequent Product CodeJDW
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-06-24
Decision Date1998-07-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H679SD2926800 K982222 000
H6799007260 K982222 000
H6799007230 K982222 000

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