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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 K170045
Device Name Swedge™ Pedicle Screw Fixation System
Applicant
Spinal Resources, Inc.
5450 Nw. 33rd Ave.
Unit 103
Fort Lauderdale,  FL  33309
Applicant Contact Bernard Bedor
Correspondent
Empirical Testing Corp
4628 Northpark Dr.
Colorado Springs,  CO  80918
Correspondent Contact Kenneth C. Maxwell
Regulation Number888.3070
Classification Product Code
NKB  
Date Received01/05/2017
Decision Date 06/26/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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