SYNTHES (USA) FLEXIBLE HUMERAL NAIL(FLEX NAIL) SYSTEM

Nail, Fixation, Bone

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Flexible Humeral Nail(flex Nail) System.

Pre-market Notification Details

Device IDK972516
510k NumberK972516
Device Name:SYNTHES (USA) FLEXIBLE HUMERAL NAIL(FLEX NAIL) SYSTEM
ClassificationNail, Fixation, Bone
Applicant SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli,  PA  19301 -1222
ContactAngela Silvestri
CorrespondentAngela Silvestri
SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli,  PA  19301 -1222
Product CodeJDS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-07-07
Decision Date1997-09-04
Summary:summary

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