Intellijoint HIP System (Cart), Intellijoint HIP System (Portable), Intellijoint HIP Instrument Tray

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 System (cart), Intellijoint Hip System (portable), Intellijoint Hip Instrument Tray.

Pre-market Notification Details

Device IDK172849
510k NumberK172849
Device Name:Intellijoint HIP System (Cart), Intellijoint HIP System (Portable), Intellijoint HIP Instrument Tray
ClassificationOrthopedic Stereotaxic Instrument
Applicant Intellijoint Surgical Inc. 60 Bathurst Drive Unit 6 Waterloo,  CA N2v 2a9
ContactBrandon Gingrich
CorrespondentBrandon Gingrich
Intellijoint Surgical Inc. 60 Bathurst Drive Unit 6 Waterloo,  CA N2v 2a9
Product CodeOLO  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-09-20
Decision Date2017-11-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00628184003732 K172849 000
00628184003763 K172849 000
00628184003770 K172849 000
00628184002827 K172849 000
00628184002834 K172849 000
00628184002841 K172849 000
00628184002858 K172849 000
00628184003664 K172849 000
00628184003688 K172849 000
00628184003862 K172849 000

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