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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-24
Decision Date2022-07-14

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840019970761 K220862 000
00840019970754 K220862 000
00840019970747 K220862 000
00840019970730 K220862 000
00840019970723 K220862 000
00840019970716 K220862 000
00840019970709 K220862 000
00840019970693 K220862 000
00840019970686 K220862 000

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