SYNTHES PROXIMAL HUMERAL NAIL

Nail, Fixation, Bone

SYNTHES (USA)

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

Pre-market Notification Details

Device IDK002729
510k NumberK002729
Device Name:SYNTHES PROXIMAL HUMERAL NAIL
ClassificationNail, Fixation, Bone
Applicant SYNTHES (USA) 1690 RUSSELL RD. Paoli,  PA  19301
ContactThomas M Maguire
CorrespondentThomas M Maguire
SYNTHES (USA) 1690 RUSSELL RD. Paoli,  PA  19301
Product CodeJDS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-09-01
Decision Date2000-10-06
Summary:summary

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