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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intervertebral Fusion Device With Bone Graft, Cervical
510(k) Number K191243
Device Name HEDRON Cervical Spacers
Applicant
Globus Medical, Inc.
2560 General Armistead Ave.
Audubon,  PA  19403
Applicant Contact Kelly Baker
Correspondent
Globus Medical, Inc.
2560 General Armistead Ave.
Audubon,  PA  19403
Correspondent Contact Kelly Baker
Regulation Number888.3080
Classification Product Code
ODP  
Subsequent Product Code
OVE  
Date Received05/09/2019
Decision Date 09/17/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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