510(k) K082468 ยท KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX AND H3-828YY, XX=OD IN [MM] (38-43), YY=OD IN [MM](44-60)
| Applicant | Omni Life Science, Inc., Raynham MA, US |
| Decision | Substantially Equivalent, Feb 18, 2009 |
| Received | Aug 27, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082468
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 10, 2009 | Omni 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 |
KWY | None listed |
| Sep 10, 2009 | Omni 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 |
KWY | None listed |
| Sep 10, 2009 | Omni 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 |
KWY | None listed |
| Sep 10, 2009 | Omni 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 |
KWY | None listed |
| Sep 10, 2009 | Omni 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 |
KWY | None listed |
| Sep 10, 2009 | Omni 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 |
KWY | None listed |
| Sep 10, 2009 | Omni 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 |
KWY | None listed |
| Sep 10, 2009 | Omni 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 |
KWY | None listed |
| Sep 10, 2009 | Omni 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 |
KWY | None listed |
| Sep 10, 2009 | Omni 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 |
KWY | None listed |
| Sep 10, 2009 | Omni 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 |
KWY | None listed |
| Sep 10, 2009 | Omni 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 |
KWY | None listed |
| Sep 10, 2009 | Omni Life Science Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 50 mm OD
Product Code: H3-82850.
Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplas Terminated |
KWY | None listed |
| Sep 10, 2009 | Omni Life Science Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 51 mm OD
Product Code: H3-82851.
Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplas Terminated |
KWY | None listed |
| Sep 10, 2009 | Omni Life Science Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 52 mm OD
Product Code: H3-82852.
Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplas Terminated |
KWY | None listed |
| Sep 10, 2009 | Omni Life Science Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 53 mm OD
Product Code: H3-82853.
Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplas Terminated |
KWY | None listed |
| Sep 10, 2009 | Omni Life Science Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 54 mm OD
Product Code: H3-82854.
Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplas Terminated |
KWY | None listed |
| Sep 10, 2009 | Omni Life Science Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 55 mm OD
Product Code: H3-82855.
Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplas Terminated |
KWY | None listed |
| Sep 10, 2009 | Omni Life Science Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 56 mm OD
Product Code: H3-82856.
Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplas Terminated |
KWY | None listed |
| Sep 10, 2009 | Omni Life Science Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 57 mm OD
Product Code: H3-82857.
Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplas Terminated |
KWY | None listed |
| Sep 10, 2009 | Omni Life Science Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 58 mm OD
Product Code: H3-82858.
Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplas Terminated |
KWY | None listed |
| Sep 10, 2009 | Omni Life Science Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 59 mm OD
Product Code: H3-82859.
Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplas Terminated |
KWY | None listed |
| Sep 10, 2009 | Omni Life Science Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 60 mm OD
Product Code: H3-82860.
Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplas Terminated |
KWY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.