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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthopedic Stereotaxic Instrument
510(k) Number K192526
Device Name Spine Wave Navigated Instruments
Applicant
Spine Wave, Inc.
3 Enterprise Dr.
Suite 210
Shelton,  CT  06484
Applicant Contact Amy Noccioli
Correspondent
Spine Wave, Inc.
3 Enterprise Dr.
Suite 210
Shelton,  CT  06484
Correspondent Contact Amy Noccioli
Regulation Number882.4560
Classification Product Code
OLO  
Date Received09/13/2019
Decision Date 10/10/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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