SYNTHES RIA SYSTEM (EXPANDED INDICATIONS)

Reamer

SYNTHES (USA) PRODUCTS LLC

The following data is part of a premarket notification filed by Synthes (usa) Products Llc with the FDA for Synthes Ria System (expanded Indications).

Pre-market Notification Details

Device IDK111437
510k NumberK111437
Device Name:SYNTHES RIA SYSTEM (EXPANDED INDICATIONS)
ClassificationReamer
Applicant SYNTHES (USA) PRODUCTS LLC 1301 GOSHEN PKWY. West Chester,  PA  19380
ContactAngela F Lassandro
CorrespondentAngela F Lassandro
SYNTHES (USA) PRODUCTS LLC 1301 GOSHEN PKWY. West Chester,  PA  19380
Product CodeHTO  
CFR Regulation Number888.4540 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-05-24
Decision Date2011-08-10
Summary:summary

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