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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Intervertebral Body
510(k) Number K200224
Device Name SEA-LINK Anterior Cervical Plate System
Applicant
Indius Medical Technologies Pvt. , Ltd.
Unit 12, Floors 1 And 2, Electronic Co-Operative Estate
Pune Satara Rd.
Pune,  IN 411009
Applicant Contact Aditya Ingalhalikar
Correspondent
Empirical Testing Corp
4628 Northpark Dr.
Colorado Springs,  CO  80918
Correspondent Contact Nathan Wright
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received01/29/2020
Decision Date 03/24/2020
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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