SBI WRISTFIT

Plate, Fixation, Bone

SMALL BONE INNOVATIONS, LLC

The following data is part of a premarket notification filed by Small Bone Innovations, Llc with the FDA for Sbi Wristfit.

Pre-market Notification Details

Device IDK051747
510k NumberK051747
Device Name:SBI WRISTFIT
ClassificationPlate, Fixation, Bone
Applicant SMALL BONE INNOVATIONS, LLC 505 PARK AVE., 14TH FLOOR New York,  NY  10022
ContactDonald Guthner
CorrespondentDonald Guthner
SMALL BONE INNOVATIONS, LLC 505 PARK AVE., 14TH FLOOR New York,  NY  10022
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-06-29
Decision Date2005-09-06
Summary:summary

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