SYNTHES UNREAMED HUMERAL NAIL (URHN)

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 Unreamed Humeral Nail (urhn).

Pre-market Notification Details

Device IDK933518
510k NumberK933518
Device Name:SYNTHES UNREAMED HUMERAL NAIL (URHN)
ClassificationRod, Fixation, Intramedullary And Accessories
Applicant SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli,  PA  19301 -1222
ContactDiane Cochet-wynant
CorrespondentDiane Cochet-wynant
SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli,  PA  19301 -1222
Product CodeHSB  
CFR Regulation Number888.3020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-07-20
Decision Date1994-03-14

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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H6794629650 K933518 000

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