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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 K201568
Device Name Calvary Spine Pedicle Screw System
Applicant
Calvary Spine, LLC
308 N. Wind Rd.
Towson,  MD  21204
Applicant Contact James Edwards
Correspondent
The OrthoMedix Group, Inc.
4313 W. 3800 S.
West Haven,  UT  84401
Correspondent Contact J.D. Webb
Regulation Number888.3070
Classification Product Code
NKB  
Date Received06/11/2020
Decision Date 11/12/2020
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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