MAXLOCK EXTREME EXTREMITY PLATING SYSTEM WITH VARIABLE ANGLE TECHNOLOGY

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 Extremity Plating System With Variable Angle Technology.

Pre-market Notification Details

Device IDK100618
510k NumberK100618
Device Name:MAXLOCK EXTREME EXTREMITY PLATING SYSTEM WITH VARIABLE ANGLE TECHNOLOGY
ClassificationPlate, Fixation, Bone
Applicant ORTHOHELIX SURGICAL DESIGNS, INC. 1065 MEDINA ROAD SUITE 500 Medina,  OH  44256
ContactDerek Lewis
CorrespondentDerek Lewis
ORTHOHELIX SURGICAL DESIGNS, INC. 1065 MEDINA ROAD SUITE 500 Medina,  OH  44256
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-03-04
Decision Date2010-04-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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00846832032556 K100618 000

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