SYNTHES (USA) LCP MODULAR FOOT PLATES

Plate, Fixation, Bone

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Lcp Modular Foot Plates.

Pre-market Notification Details

Device IDK050110
510k NumberK050110
Device Name:SYNTHES (USA) LCP MODULAR FOOT PLATES
ClassificationPlate, Fixation, Bone
Applicant SYNTHES (USA) 1690 RUSSELL RD. Paoli,  PA  19301
ContactKathy Anderson
CorrespondentKathy Anderson
SYNTHES (USA) 1690 RUSSELL RD. Paoli,  PA  19301
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-01-18
Decision Date2005-03-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H679021000230 K050110 000
H6794028840 K050110 000
H6794028820 K050110 000
H6794028800 K050110 000
H6794028780 K050110 000
H6794028760 K050110 000
H6794028740 K050110 000
H6794028720 K050110 000
H6794028700 K050110 000
H6794017900 K050110 000
H6794017880 K050110 000
H6794017860 K050110 000
H6794017840 K050110 000
H6794017820 K050110 000
H6794028860 K050110 000
H6794028880 K050110 000
H679021000220 K050110 000
H679021000210 K050110 000
H679021000200 K050110 000
H679041000230 K050110 000
H679041000220 K050110 000
H679041000210 K050110 000
H679041000200 K050110 000
H6794029000 K050110 000
H6794028980 K050110 000
H6794028960 K050110 000
H6794028940 K050110 000
H6794028920 K050110 000
H6794028900 K050110 000
H6794017800 K050110 000

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