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U.S. Department of Health and Human Services

Devices@FDA
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Note: if a medical device has supplements, the device description and instructions may have
changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
 
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11 supplements returned for P190009

New Search  Back to Search Results | Help
Device Name Company Date Approved Supplement Reason Other Information
opra implant system

Integrum AB Dec 18, 2020   Approval Order
Summary of Safety & Effectiveness
Labeling &  Labeling 2
opra implant system

supplement #: S001
Integrum AB Feb 12, 2021 postapproval study protocol  
opra system

supplement #: S002
Integrum AB Feb 12, 2021 postapproval study protocol  
opra™ system

supplement #: S003
Integrum AB Apr 21, 2023 change design/components/specifications/material  
opra implant system

supplement #: S004
Integrum AB Dec 21, 2023 change design/components/specifications/material  
opra implant system

supplement #: S005
Integrum AB Apr 09, 2024 change design/components/specifications/material  
opra implant system, abutment component

supplement #: S006
Integrum AB Nov 20, 2025 process change - manufacturer/sterilizer/packager/supplier  
opra™ implant system

supplement #: S007
Integrum AB Jan 15, 2025 postapproval study protocol  
opra™ implant system

supplement #: S009
Integrum AB Aug 14, 2025 postapproval study protocol  
opra implant system

supplement #: S010
Integrum AB Mar 12, 2026 labeling change - pas  
  We welcome your comments and feedback about Devices@FDA.
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