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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 K101812
Device Name CONSTRUX MINI PEEK SPACER SYSTEM
Applicant
Orthofix, Inc.
1720 Bray Central Dr.
Mckinney,  TX  75069
Applicant Contact RUSSELL JOHNSON
Correspondent
Orthofix, Inc.
1720 Bray Central Dr.
Mckinney,  TX  75069
Correspondent Contact RUSSELL JOHNSON
Regulation Number888.3080
Classification Product Code
ODP  
Subsequent Product Code
MQP  
Date Received06/29/2010
Decision Date 09/27/2010
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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