ClearanceBrief
Panels › Orthopedic › Product code KWY · Class 2

Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented

Regulation 888.3390

1510(k)s in 12 months (99 all time)
0recalls in 12 months (88 all time)
86recalls that name a 510(k)
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Top companies in KWY

DateFirm and productCodeLinked 510(k)
Sep 10, 2009Omni Life Science
Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 49 mm OD Product Code: H3-82849. Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplas
Terminated
KWYK082468
Sep 10, 2009Omni Life Science
Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 48 mm OD Product Code: H3-82848. Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplas
Terminated
KWYK082468
Sep 10, 2009Omni Life Science
Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 47 mm OD Product Code: H3-82847. Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplas
Terminated
KWYK082468
Sep 10, 2009Omni Life Science
Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 46 mm OD Product Code: H3-82846. Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplas
Terminated
KWYK082468
Sep 10, 2009Omni Life Science
Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 45 mm OD Product Code: H3-82845. Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplas
Terminated
KWYK082468
Sep 10, 2009Omni Life Science
Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 44 mm OD Product Code: H3-82844. Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplas
Terminated
KWYK082468
Sep 10, 2009Omni Life Science
Apex Hip System Bipolar Head, 22.225mm ID, 43 mm OD Product Code: H3-82243. Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplasty of the
Terminated
KWYK082468
Sep 10, 2009Omni Life Science
Apex Hip System Bipolar Head, 22.225mm ID, 42 mm OD Product Code: H3-82242. Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplasty of the
Terminated
KWYK082468
Sep 10, 2009Omni Life Science
Apex Hip System Bipolar Head, 22.225mm ID, 41 mm OD Product Code: H3-82241. Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplasty of the
Terminated
KWYK082468
Sep 10, 2009Omni Life Science
Apex Hip System Bipolar Head, 22.225mm ID, 40 mm OD Product Code: H3-82240. Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplasty of the
Terminated
KWYK082468
Sep 10, 2009Omni Life Science
Apex Hip System Bipolar Head, 22.225mm ID, 39 mm OD Product Code: H3-82239. Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplasty of the
Terminated
KWYK082468
Sep 10, 2009Omni Life Science
Apex Hip System Bipolar Head, 22.225mm ID, 38 mm OD Product Code: H3-82238. Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplasty of the
Terminated
KWYK082468
Sep 11, 2008Stryker Howmedica Osteonics Corp.
Scorpio Total Knee Posteriorly Stabilized Femoral Component, #7R, Catalog No.: 71-4107R, Lot Code: K05L310; Scorpio Total Knee Posteriorly Stabilized Femoral Component, #7L, Catalog No. 71-4506L, Lot
Terminated
KWYK962152
Nov 7, 2007Encore Medical, Lp
Foundation Hip System Bipolar Modular, Size 60mm OD; Cat. #412-01-060; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758.
Terminated
KWYK953510
Nov 7, 2007Encore Medical, Lp
Foundation Hip System Bipolar Modular, Size 58mm OD; Cat. #412-01-058; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758.
Terminated
KWYK953510
Nov 7, 2007Encore Medical, Lp
Foundation Hip System Bipolar Modular, Size 56mm OD; Cat. #412-01-056; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758.
Terminated
KWYK953510
Nov 7, 2007Encore Medical, Lp
Foundation Hip System Bipolar Modular, Size 54mm OD; Cat. #412-01-054; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758.
Terminated
KWYK953510
Nov 7, 2007Encore Medical, Lp
Foundation Hip System Bipolar Modular, Size 53mm OD; Cat. #412-01-053; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758.
Terminated
KWYK953510
Nov 7, 2007Encore Medical, Lp
Foundation Hip System Bipolar Modular, Size 52mm OD; Cat. #412-01-052; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758.
Terminated
KWYK953510
Nov 7, 2007Encore Medical, Lp
Foundation Hip System Bipolar Modular, Size 51mm OD; Cat. #412-01-051; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758.
Terminated
KWYK953510
Nov 7, 2007Encore Medical, Lp
Foundation Hip System Bipolar Modular, Size 50mm OD; Cat. #412-01-050; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758.
Terminated
KWYK953510
Nov 7, 2007Encore Medical, Lp
Foundation Hip System Bipolar Modular, Size 49mm OD; Cat. #412-01-049; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758.
Terminated
KWYK953510
Nov 7, 2007Encore Medical, Lp
Foundation Hip System Bipolar Modular, Size 48mm OD; Cat. #412-01-048; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758.
Terminated
KWYK953510
Nov 7, 2007Encore Medical, Lp
Foundation Hip System Bipolar Modular, Size 47mm OD; Cat. #412-01-047; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758.
Terminated
KWYK953510
Nov 7, 2007Encore Medical, Lp
Foundation Hip System Bipolar Modular, Size 46mm OD; Cat. #412-01-046; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758.
Terminated
KWYK953510
Nov 7, 2007Encore Medical, Lp
Foundation Hip System Bipolar Modular, Size 45mm OD; Cat. #412-01-045; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758.
Terminated
KWYK953510
Nov 7, 2007Encore Medical, Lp
Foundation Hip System Bipolar Modular, Size 44mm OD; Cat. #412-01-044; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758.
Terminated
KWYK953510
Nov 7, 2007Encore Medical, Lp
Foundation Hip System Bipolar Modular, Size 43mm OD; Cat. #412-01-043; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758.
Terminated
KWYK953510
Nov 7, 2007Encore Medical, Lp
Foundation Hip System Bipolar Modular, Size 42mm OD; Cat. #412-01-042; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758.
Terminated
KWYK953510
Nov 7, 2007Encore Medical, Lp
Foundation Hip System Bipolar Modular, Size 41mm OD; Cat. #412-01-041; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758.
Terminated
KWYK953510
Nov 7, 2007Encore Medical, Lp
Foundation Hip System Bipolar Modular, Size 40mm OD; Cat. #412-01-040; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758.
Terminated
KWYK953510
Mar 7, 2007Wright Medical Technology Inc
Wright Medical Technology, Gladiator Bipolar Hip Prosthesis, REF: GLBP-3655, Size 55mm O.D., use with 36 mm Head
Terminated
KWYNone listed
Mar 7, 2007Wright Medical Technology Inc
Wright Medical Technology, Gladiator Bipolar Hip Prosthesis, REF: GLBP-3654, Size 54mm O.D., use with 36 mm Head
Terminated
KWYK062693
Mar 7, 2007Wright Medical Technology Inc
Wright Medical Technology, Gladiator Bipolar Hip Prosthesis, REF: GLBP-3653, Size 53mm O.D., use with 36 mm Head
Terminated
KWYK062693
Mar 7, 2007Wright Medical Technology Inc
Wright Medical Technology, Gladiator Bipolar Hip Prosthesis, REF: GLBP-3652, Size 52mm O.D., use with 36 mm Head
Terminated
KWYK062693
Mar 7, 2007Wright Medical Technology Inc
Wright Medical Technology, Gladiator Bipolar Hip Prosthesis, REF: GLBP-3651, Size 51mm O.D., use with 36 mm Head
Terminated
KWYK062693
Mar 7, 2007Wright Medical Technology Inc
Wright Medical Technology, Gladiator Bipolar Hip Prosthesis, REF: GLBP-3650, Size 50mm O.D., use with 36 mm Head
Terminated
KWYK062693
Mar 7, 2007Wright Medical Technology Inc
Wright Medical Technology, Gladiator Bipolar Hip Prosthesis, REF: GLBP-2241, Size 41mm O.D., use with 22 mm Head
Terminated
KWYK062693

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