CoreLink Navigation Instruments

Orthopedic Stereotaxic Instrument

CoreLink, LLC

The following data is part of a premarket notification filed by Corelink, Llc with the FDA for Corelink Navigation Instruments.

Pre-market Notification Details

Device IDK220973
510k NumberK220973
Device Name:CoreLink Navigation Instruments
ClassificationOrthopedic Stereotaxic Instrument
Applicant CoreLink, LLC 2072 Fenton Logistics Park St. Louis,  MO  63026
ContactSteven Mounts
CorrespondentNathan Wright
Empirical Testing Corp. 4628 Northpark Drive Colorado Springs,  CO  80918
Product CodeOLO  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-04-04
Decision Date2022-06-01

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