3 results
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20ms
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Sources: EU EUDAMED, US FDA
OP7543 Design Y Mandible Onlay - Medium - Left and OP7544 Design Y Mandible Onlay - Medium - Right
FDA Enforcement
Class II
·Terminated·Matrix Surgical Holdings, LLC·March 8, 2017
OMNIPORE Surgical Implant Petite Paranasal - Left - Product Usage: OmniPore Surgical Implants in block, sheet, and anatomical shapes are intended for nonweight bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. OmniPore Surgical Implants are also intended for the augmentation or restoration of contour in the craniomaxillofacial skeleton.
FDA Enforcement
Class II
·Terminated·Matrix Surgical Holdings, LLC·May 8, 2019
OMNIPORE Surgical Implant Petite Paranasal - Right - Product Usage: OmniPore Surgical Implants in block, sheet, and anatomical shapes are intended for nonweight bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. OmniPore Surgical Implants are also intended for the augmentation or restoration of contour in the craniomaxillofacial skeleton.
FDA Enforcement
Class II
·Terminated·Matrix Surgical Holdings, LLC·May 8, 2019