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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thoracolumbosacral Pedicle Screw System
510(k) Number K230974
Device Name NIDO™ Pedicle Screw System
Applicant
Kalitec Medical
618 E. S. St., Suite 500
Orlando,  FL  32801
Applicant Contact Keith Cannon
Correspondent
MCRA
803 7th St. NW
Washington,  DC  20001
Correspondent Contact Justin Eggleton
Regulation Number888.3070
Classification Product Code
NKB  
Date Received04/05/2023
Decision Date 09/15/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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