8 results
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34ms
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Sources: EU EUDAMED, US FDA
PS-C Femoral Nonporous Rt Sz 6, Model Number 161-1604 Component of the Balanced Knee System and Balanced Knee Revision System, for total knee arthroplasty procedures.
FDA Enforcement
Class II
·Terminated·Ortho Development Corporation·May 21, 2014
PS Tibial Insert, REF 163-1XXX Product Usage: UHMWPE component used in TKA procedures to serve as a tibial bearing surface for articulation with the femoral component
FDA Enforcement
Class II
·Terminated·Ortho Development Corporation·August 27, 2014
Tibila Insert CK, Balanced Knee System Revision, REF563-1YYY Product Usage: UHMWPE component used in TKA and revision TKA procedures to serve as a tibial bearing surface for articulation with the femoral component where additional joint constraint is needed
FDA Enforcement
Class II
·Terminated·Ortho Development Corporation·August 27, 2014
Pivot Bipolar Cup 22x42/43-51/53mm, REF 133-YYYY Product Usage: Used in a hemiarthroplasty procedure as the bearing surface to articulate with both the CoCr femoral head and the natural acetabulum
FDA Enforcement
Class II
·Terminated·Ortho Development Corporation·August 27, 2014
Tibila Insert UC, Balanced Knee System, REF163-3YYY Product Usage: UHMWPE component used in TKA procedures to serve as a tibial bearing surface for articulation with the femoral component
FDA Enforcement
Class II
·Terminated·Ortho Development Corporation·August 27, 2014
Patella 38mm, REF164-0038 Product Usage: UHMWPE component used in a TKA procedure to resurface the patella and serve as a bearing surface for sliding contact with the femoral component
FDA Enforcement
Class II
·Terminated·Ortho Development Corporation·August 27, 2014
Tibial Tray Nonporous A Size 2; Model # PN 162-1200-A; Material: Ti6Al4V.
FDA Enforcement
Class II
·Ongoing·Ortho Development Corporation·May 13, 2020
Tibial Tray Nonporous A Size 4; Model # PN 162-1400-A Material: Ti6Al4V.
FDA Enforcement
Class II
·Ongoing·Ortho Development Corporation·May 13, 2020