OIC CANNULATED SCREW SYSTEM, OIC SLIDING HIP SCREW (SHS) SYSTEM

Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

THE ORTHOPAEDIC IMPLANT COMPANY

The following data is part of a premarket notification filed by The Orthopaedic Implant Company with the FDA for Oic Cannulated Screw System, Oic Sliding Hip Screw (shs) System.

Pre-market Notification Details

Device IDK113123
510k NumberK113123
Device Name:OIC CANNULATED SCREW SYSTEM, OIC SLIDING HIP SCREW (SHS) SYSTEM
ClassificationAppliance, Fixation, Nail/blade/plate Combination, Multiple Component
Applicant THE ORTHOPAEDIC IMPLANT COMPANY 5401 S. COTTONWOOD CT. Greenwood Village,  CO  80121
ContactKevin Walls
CorrespondentKevin Walls
THE ORTHOPAEDIC IMPLANT COMPANY 5401 S. COTTONWOOD CT. Greenwood Village,  CO  80121
Product CodeKTT  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-10-21
Decision Date2012-01-12

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10811998030224 K113123 000
10811998032266 K113123 000
M6960173120 K113123 000
M6960173140 K113123 000
M6960173150 K113123 000
M6960173160 K113123 000
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M69601SHS0210 K113123 000
M69601SHS0220 K113123 000
M69601SHS0230 K113123 000
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M6960145TP0 K113123 000
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M69601SHS120 K113123 000
10811998030194 K113123 000
10811998032136 K113123 000
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M69601SHS050 K113123 000
M69601SHS060 K113123 000
M69601SHS070 K113123 000
M69601SHS200 K113123 000
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M69601SHS150 K113123 000
M69601SHS160 K113123 000
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M69601SHS040 K113123 000
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M6960140050 K113123 000
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M6960173110 K113123 000
M69601SHS080 K113123 000
M69601SHS090 K113123 000
M69601SHS170 K113123 000
M69601SHS180 K113123 000
M69601SHS190 K113123 000
10811998030064 K113123 000
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10811998032105 K113123 000
10811998032112 K113123 000
10811998032129 K113123 000
10811998032259 K113123 000
20811998035394 K113123 000

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