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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name intervertebral fusion device with bone graft, lumbar
510(k) Number K213653
Device Name 4CIS BLACK MARLIN PLIF CAGE SYSTEM, 4CIS DOLPHIN TLIF CAGE SYSTEM
Applicant
Solco Biomedical Company India Private Limited
5 & 6 Third FloorB. Jadav Chambers, Above Sales India
Ahmedabad,  IN 380009
Applicant Contact Darshak Shah
Correspondent
Solco Biomedical Company India Private Limited
5 & 6 Third FloorB. Jadav Chambers, Above Sales India
Ahmedabad,  IN 380009
Correspondent Contact Darshak Shah
Regulation Number888.3080
Classification Product Code
MAX  
Date Received11/19/2021
Decision Date 12/19/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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