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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 K141333
Device Name ARENA-C TIFUSE CERVICAL INTERVERTEBRAL BODY FUSION DEVICE
Applicant
Spinefrontier, Inc.
4628 Northpark Dr.
Colorado Springs,  CO  80918
Applicant Contact MEREDITH MAY MS, RAC
Correspondent
Spinefrontier, Inc.
4628 Northpark Dr.
Colorado Springs,  CO  80918
Correspondent Contact MEREDITH MAY MS, RAC
Regulation Number888.3080
Classification Product Code
ODP  
Date Received05/21/2014
Decision Date 11/25/2014
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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