Intellijoint HIP Generation 2A System

Orthopedic Stereotaxic Instrument

INTELLIJOINT SURGICAL INC.

The following data is part of a premarket notification filed by Intellijoint Surgical Inc. with the FDA for Intellijoint Hip Generation 2a System.

Pre-market Notification Details

Device IDK162364
510k NumberK162364
Device Name:Intellijoint HIP Generation 2A System
ClassificationOrthopedic Stereotaxic Instrument
Applicant INTELLIJOINT SURGICAL INC. 60 BATHURST DR., UNIT 6 Waterloo,  CA N2v 2a9
ContactBrandon Gingrich
CorrespondentBrandon Gingrich
INTELLIJOINT SURGICAL INC. 60 BATHURST DR., UNIT 6 Waterloo,  CA N2v 2a9
Product CodeOLO  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-08-23
Decision Date2017-03-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00628184003589 K162364 000
00628184003565 K162364 000
00628184003008 K162364 000
00628184002803 K162364 000
00628184002759 K162364 000

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