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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 K211704
Device Name CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer System, CONSTRUX Mini Ti Spacer System, FORZA PEEK Spacer System, FORZA PTC Spacer System, FORZA Ti Spacer System, FORZA XP Expandable Spacer System, Lonestar Cervical Standalone System, PILLAR PEEK Spacer Syst
Applicant
Orthofix Inc.
3451 Plano Parkway
Lewisville,  TX  75056
Applicant Contact Jacki Koch
Correspondent
Orthofix Inc.
3451 Plano Parkway
Lewisville,  TX  75056
Correspondent Contact Jacki Koch
Regulation Number888.3080
Classification Product Code
ODP  
Subsequent Product Codes
MAX   MQP   OVD   OVE  
Date Received06/03/2021
Decision Date 08/31/2021
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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