INTRAOSSEOUS FIXATION SYSTEM

Pin, Fixation, Smooth

ORTHOHELIX SURGICAL DESIGNS, INC.

The following data is part of a premarket notification filed by Orthohelix Surgical Designs, Inc. with the FDA for Intraosseous Fixation System.

Pre-market Notification Details

Device IDK120165
510k NumberK120165
Device Name:INTRAOSSEOUS FIXATION SYSTEM
ClassificationPin, Fixation, Smooth
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 CodeHTY  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-01-19
Decision Date2012-04-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00846832035656 K120165 000
00846832035649 K120165 000
00846832035601 K120165 000
00846832035571 K120165 000
00846832035533 K120165 000
00846832035526 K120165 000
00846832035489 K120165 000
00846832035472 K120165 000
00846832035441 K120165 000

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