Black Diamond Navigation Instruments

Orthopedic Stereotaxic Instrument

Osseus Fusion Systems

The following data is part of a premarket notification filed by Osseus Fusion Systems with the FDA for Black Diamond Navigation Instruments.

Pre-market Notification Details

Device IDK192495
510k NumberK192495
Device Name:Black Diamond Navigation Instruments
ClassificationOrthopedic Stereotaxic Instrument
Applicant Osseus Fusion Systems 2703 Mockingbird Lane, Suite 102 Dallas,  TX  75235
ContactRobert Pace
CorrespondentJ. D. Webb
The OrthoMedix Group, Inc. 4313 W. 3800 S. West Haven,  UT  84401
Product CodeOLO  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyNeurology
510k Review PanelOrthopedic
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-11
Decision Date2020-01-17

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