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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spinous Process Plate
510(k) Number K180156
Device Name SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation System
Applicant
Globus Medical, Inc.
2560 General Armistead Ave.
Audubon,  PA  19403
Applicant Contact Lori Burns
Correspondent
Globus Medical, Inc.
2560 General Armistead Ave.
Audubon,  PA  19403
Correspondent Contact Lori Burns
Regulation Number888.3050
Classification Product Code
PEK  
Subsequent Product Code
NQW  
Date Received01/19/2018
Decision Date 03/07/2018
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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