AEQUALIS HUMERAL NAIL; SIZES 7MM & 8MM X 210, 230, 250, 270MM; LEFT AND RIGHT

Rod, Fixation, Intramedullary And Accessories

TORNIER, INC.

The following data is part of a premarket notification filed by Tornier, Inc. with the FDA for Aequalis Humeral Nail; Sizes 7mm & 8mm X 210, 230, 250, 270mm; Left And Right.

Pre-market Notification Details

Device IDK133376
510k NumberK133376
Device Name:AEQUALIS HUMERAL NAIL; SIZES 7MM & 8MM X 210, 230, 250, 270MM; LEFT AND RIGHT
ClassificationRod, Fixation, Intramedullary And Accessories
Applicant TORNIER, INC. 10801 Nesbitt Avenue South Bloomington,  MN  55437
ContactJanell A Colley
CorrespondentJanell A Colley
TORNIER, INC. 10801 Nesbitt Avenue South Bloomington,  MN  55437
Product CodeHSB  
CFR Regulation Number888.3020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-11-04
Decision Date2013-12-05
Summary:summary

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