RHEAD RADIAL HEAD EXTENDED STEMS

Prosthesis, Elbow, Semi-constrained, Cemented

SMALL BONE INNOVATIONS, INC.

The following data is part of a premarket notification filed by Small Bone Innovations, Inc. with the FDA for Rhead Radial Head Extended Stems.

Pre-market Notification Details

Device IDK102180
510k NumberK102180
Device Name:RHEAD RADIAL HEAD EXTENDED STEMS
ClassificationProsthesis, Elbow, Semi-constrained, Cemented
Applicant SMALL BONE INNOVATIONS, INC. 1380 S. PENNSYLVANIA AVE. Morrisville,  PA  19067
ContactJames O'connor
CorrespondentJames O'connor
SMALL BONE INNOVATIONS, INC. 1380 S. PENNSYLVANIA AVE. Morrisville,  PA  19067
Product CodeJDB  
CFR Regulation Number888.3160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-08-02
Decision Date2010-12-20
Summary:summary

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