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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 K240233
Device Name Pitkar Spinal Pedicle Screw System
Applicant
S.H.Pitkar Orthotools Pvt. , Ltd.
Plot # El 32, J Block, Midc Bhosari
Pune,  IN 411026
Applicant Contact Vivek Mangalwedhekar
Correspondent
S.H.Pitkar Orthotools Pvt. , Ltd.
Plot # El 32, J Block, Midc Bhosari
Pune,  IN 411026
Correspondent Contact Vivek Mangalwedhekar
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ  
Date Received01/29/2024
Decision Date 09/09/2024
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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