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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 K180980
Device Name ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization System
Applicant
Camber Spine Technologies, LLC
418 E. Lancaster Ave.
Wayne,  PA  19087
Applicant Contact Tom Zamorski
Correspondent
RQMIS, Inc.
110 Haverhill Rd., Suite 526
Amesbury,  MA  01913
Correspondent Contact Manjusha Bharadwaj
Regulation Number888.3070
Classification Product Code
NKB  
Date Received04/13/2018
Decision Date 10/27/2018
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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