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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 K232607
Device Name 4CIS SARA SPINE SYSTEM, 4CIS VERTU SPINE SYSTEM, 4CIS WILL PEDICLE SCREW SYSTEM, aBle SPINAL FIXATION SYSTEM, aBle Xt SPINAL FIXATION SYSTEM
Applicant
Solco Biomedical Copany India Private Limited
Survey #1540, Beside Torrent Pharma,
Village-Rajpur Ahmedabad Mehsana Highway
Kadi,  IN 382715
Applicant Contact Darshak Shah
Correspondent
Solco Biomedical Copany India Private Limited
Survey #1540, Beside Torrent Pharma,
Village-Rajpur Ahmedabad Mehsana Highway
Kadi,  IN 382715
Correspondent Contact Darshak Shah
Regulation Number888.3070
Classification Product Code
NKB  
Date Received08/28/2023
Decision Date 02/27/2024
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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