MAXLOCK EXTREME SYSTEM MODEL MXL

Plate, Fixation, Bone

ORTHOHELIX SURGICAL DESIGNS, INC.

The following data is part of a premarket notification filed by Orthohelix Surgical Designs, Inc. with the FDA for Maxlock Extreme System Model Mxl.

Pre-market Notification Details

Device IDK123203
510k NumberK123203
Device Name:MAXLOCK EXTREME SYSTEM MODEL MXL
ClassificationPlate, Fixation, Bone
Applicant ORTHOHELIX SURGICAL DESIGNS, INC. 1065 Medina Rd. SUITE 500 Medina,  OH  44256
ContactDerek Lewis
CorrespondentDerek Lewis
ORTHOHELIX SURGICAL DESIGNS, INC. 1065 Medina Rd. SUITE 500 Medina,  OH  44256
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-10-12
Decision Date2012-12-14
Summary:summary

NIH GUDID Devices

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