Brainlab Compatible K2M Navigation Instruments

Orthopedic Stereotaxic Instrument

K2M, Inc.

The following data is part of a premarket notification filed by K2m, Inc. with the FDA for Brainlab Compatible K2m Navigation Instruments.

Pre-market Notification Details

Device IDK192911
501k NumberK192911
Device Name:Brainlab Compatible K2M Navigation Instruments
ClassificationOrthopedic Stereotaxic Instrument
Applicant K2M, Inc. 600 Hope Parkway SE Leesburg,  VA  20175
ContactOonagh Lahiff
CorrespondentMegan Callanan
Stryker 2 Pearl Court Allendale,  NJ  07401
Product CodeOLO  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyNeurology
501k Review PanelOrthopedic
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-15
Decision Date2019-11-14

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