RAPIDSORB PLUS SCREW SYSTEM

Screw, Fixation, Intraosseous

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Rapidsorb Plus Screw System.

Pre-market Notification Details

Device IDK093464
510k NumberK093464
Device Name:RAPIDSORB PLUS SCREW SYSTEM
ClassificationScrew, Fixation, Intraosseous
Applicant SYNTHES (USA) 1230 WILSON DRIVE West Chester,  PA  19380
ContactSusan Lewandowski
CorrespondentSusan Lewandowski
SYNTHES (USA) 1230 WILSON DRIVE West Chester,  PA  19380
Product CodeDZL  
CFR Regulation Number872.4880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-11-06
Decision Date2010-01-25
Summary:summary

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