E-GPS Navigated Instruments

Orthopedic Stereotaxic Instrument

Precision Spine, Inc.

The following data is part of a premarket notification filed by Precision Spine, Inc. with the FDA for E-gps Navigated Instruments.

Pre-market Notification Details

Device IDK220862
510k NumberK220862
Device Name:E-GPS Navigated Instruments
ClassificationOrthopedic Stereotaxic Instrument
Applicant Precision Spine, Inc. 2050 Executive Dr. Pearl,  MS  39208
ContactMichael Dawson
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 Received2022-03-24
Decision Date2022-07-14

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