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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 K203367
Device Name LineSider™ Spinal System
Applicant
Integrity Implants, Inc.
354 Hiatt Dr.
Palm Beach Gardens,  FL  33418
Applicant Contact Lauren Kamer
Correspondent
Empirical Testing Corp
4628 Northpark Dr.
Colorado Springs,  CO  80918
Correspondent Contact Nathan Wright
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Code
KWP  
Date Received11/16/2020
Decision Date 12/03/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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