SYNTHES (USA) STAINLESS STEEL ELASTIC INTRAMEDULLARY NAIL SYSTEM

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) Stainless Steel Elastic Intramedullary Nail System.

Pre-market Notification Details

Device IDK081452
510k NumberK081452
Device Name:SYNTHES (USA) STAINLESS STEEL ELASTIC INTRAMEDULLARY NAIL SYSTEM
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 Received2008-05-23
Decision Date2008-07-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H6792759050 K081452 000
H679275900 K081452 000
H6792759400 K081452 000
H6792759350 K081452 000
H6792759300 K081452 000
H6792759250 K081452 000
H6792759200 K081452 000
H6792759150 K081452 000

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