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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 K150130
Device Name Ascendant TM Cervical Spacer System
Applicant
Exactech, Inc.
2320 NW 66th Ct.
Gainesville,  FL  32653
Applicant Contact DAWN DAVISSON
Correspondent
Empirical Testing Corporation
4628 Northpark Dr.
Colorado Springs,  CO  80918
Correspondent Contact KENNETH C. MAXWELL
Regulation Number888.3080
Classification Product Code
ODP  
Date Received01/21/2015
Decision Date 05/28/2015
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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