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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 K191575
Device Name ARx Spinal System
Applicant
Life Spine Inc.
13951 S Quality Drive
huntley,  IL  60142
Applicant Contact angela batker
Correspondent
Life Spine Inc.
13951 S Quality Drive
huntley,  IL  60142
Correspondent Contact angela batker
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Code
KWP  
Date Received06/14/2019
Decision Date 08/08/2019
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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