SYNTHES (USA) [SYNTHES] ANGULAR STABLE LOCKING SYSTEM (ASLS)

Rod, Fixation, Intramedullary And Accessories

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) [synthes] Angular Stable Locking System (asls).

Pre-market Notification Details

Device IDK061910
510k NumberK061910
Device Name:SYNTHES (USA) [SYNTHES] ANGULAR STABLE LOCKING SYSTEM (ASLS)
ClassificationRod, Fixation, Intramedullary And Accessories
Applicant SYNTHES (USA) 1301 GOSHEN PKWY West Chester,  PA  19380
ContactSheri L Musgnung
CorrespondentSheri L Musgnung
SYNTHES (USA) 1301 GOSHEN PKWY West Chester,  PA  19380
Product CodeHSB  
CFR Regulation Number888.3020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-07-06
Decision Date2006-09-21
Summary:summary

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