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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurosurgical Nerve Locator
510(k) Number K220160
Device Name PediGuard Threaded
Applicant
Spineguard S.A.
10 Cours Louis Lumiere
Vincennes,  FR 94300
Applicant Contact Stephane Bette
Correspondent
Hogan Lovells Llp
555 Thirteenth St. NW
Washington,  DC  20004
Correspondent Contact John Smith
Regulation Number874.1820
Classification Product Code
PDQ  
Subsequent Product Code
ETN  
Date Received01/19/2022
Decision Date 03/31/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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