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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 K121649
Device Name CONSTRUX MINI PEEK TI SPACER SYSTEM
Applicant
ORTHOFIX
3451 PLANO PARKWAY
LEWISVILLE,  TX  75056
Applicant Contact NATALIA VOLOSEN
Correspondent
ORTHOFIX
3451 PLANO PARKWAY
LEWISVILLE,  TX  75056
Correspondent Contact NATALIA VOLOSEN
Regulation Number888.3080
Classification Product Code
ODP  
Date Received06/05/2012
Decision Date 11/29/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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