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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 K160222
Device Name OIC Cervical PEEK Spacer
Applicant
The Orthopaedic Implant Company
316 California Ave. #701
Reno,  NV  89509
Applicant Contact DOUGLAS FULTON
Correspondent
The Orthopaedic Implant Company
316 California Ave. #701
Reno,  NV  89509
Correspondent Contact DOUGLAS FULTON
Regulation Number888.3080
Classification Product Code
ODP  
Date Received01/29/2016
Decision Date 12/07/2016
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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