SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) END CAP, LINE EXTENSION

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) Elastic Intramedullary Nail (ein) End Cap, Line Extension.

Pre-market Notification Details

Device IDK082148
510k NumberK082148
Device Name:SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) END CAP, LINE EXTENSION
ClassificationRod, Fixation, Intramedullary And Accessories
Applicant SYNTHES (USA) 1301 GOSHEN PKWY. West Chester,  PA  19380
ContactJill R Sherman
CorrespondentJill R Sherman
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 Received2008-07-30
Decision Date2008-08-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H679475905S0 K082148 000
H6794759050 K082148 000

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