7 results
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42ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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Omnilife Science Apex Knee System Modular Tibia Augment, Size 2 x 4mm Ref: KC-54020. The Apex Knee System is intended for use as a primary or revision total knee replacement.
FDA Enforcement
Class II
·Terminated·Omni Life Science·September 19, 2012
Omnilife Science Apex Knee System Modular Tibia Augment, Size 3 x 4mm Ref: KC-54030. The Apex Knee System is intended for use as a primary or revision total knee replacement.
FDA Enforcement
Class II
·Terminated·Omni Life Science·September 19, 2012
Omnilife Science Apex Knee System Modular Tibia Augment, Size 5 x 4mm Ref: KC-54050. The Apex Knee System is intended for use as a primary or revision total knee replacement.
FDA Enforcement
Class II
·Terminated·Omni Life Science·September 19, 2012
Omnilife Science Apex Knee System Modular Tibia Augment, Size 4 x 4mm Ref: KC-54040. The Apex Knee System is intended for use as a primary or revision total knee replacement.
FDA Enforcement
Class II
·Terminated·Omni Life Science·September 19, 2012
Omnilife Science Apex Knee System Modular Tibia Augment, Size 1 x 4mm Ref: KC-54010. The Apex Knee System is intended for use as a primary or revision total knee replacement.
FDA Enforcement
Class II
·Terminated·Omni Life Science·September 19, 2012
Omnilife Science Apex Knee System Modular Tibia Augment, Size 6 x 4mm Ref: KC-54060. The Apex Knee System is intended for use as a primary or revision total knee replacement.
FDA Enforcement
Class II
·Terminated·Omni Life Science·September 19, 2012
OMNIBotics Tracker Kit -Model: RM-10000 The TOTAL KNEE SURGETICS Navigation System with iBlock (Now OMNIBotics) is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures. It is specifically indicated for: Total Knee Arthroplasty
FDA Enforcement
Class III
·Terminated·OMNI LIFE SCIENCE·November 23, 2016