SYNTHES (USA) LCP CURVED PLATES

Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

SYNTHES (USA)

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

Pre-market Notification Details

Device IDK041911
510k NumberK041911
Device Name:SYNTHES (USA) LCP CURVED PLATES
ClassificationAppliance, Fixation, Nail/blade/plate Combination, Multiple Component
Applicant SYNTHES (USA) 1690 RUSSELL RD. Paoli,  PA  19301
ContactLisa M Boyle
CorrespondentLisa M Boyle
SYNTHES (USA) 1690 RUSSELL RD. Paoli,  PA  19301
Product CodeKTT  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-07-15
Decision Date2004-09-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H67902001332S0 K041911 000
H679020013060 K041911 000
H67902001304S0 K041911 000
H679020013040 K041911 000
H67902001302S0 K041911 000
H679020013020 K041911 000
H67902001300S0 K041911 000
H679020013000 K041911 000
H679226762S0 K041911 000
H679226742S0 K041911 000
H679226722S0 K041911 000
H679226702S0 K041911 000
H679426762S0 K041911 000
H679426742S0 K041911 000
H679426722S0 K041911 000
H67902001306S0 K041911 000
H679020013080 K041911 000
H67902001330S0 K041911 000
H67902001328S0 K041911 000
H679020013280 K041911 000
H67902001326S0 K041911 000
H679020013260 K041911 000
H67902001324S0 K041911 000
H679020013240 K041911 000
H67902001322S0 K041911 000
H679020013220 K041911 000
H67902001320S0 K041911 000
H679020013200 K041911 000
H67902001312S0 K041911 000
H67902001310S0 K041911 000
H67902001308S0 K041911 000
H679426702S0 K041911 000

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