Atlas FDA

APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX AND H3-828YY, XX=OD IN [MM] (38-43), YY=OD IN [MM](44-60)

FDA 510(k) clearance K082468 · decided 2009-02-18

Clearance details

K-number
K082468
Device name
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.
Decision
Substantially Equivalent
Date received
2008-08-27
Decision date
2009-02-18
Days to decision
175 days
Clearance type
Traditional
Product code
KWY
Device class
2
Regulation number
888.3390
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Raynham, MA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Apex Hip System Bipolar Head, 22.225mm ID, 38 mm OD Product Code: H3-82238. Intended for u recall (Z-1966-2009)Omni Life Science2009-09-10
Apex Hip System Bipolar Head, 22.225mm ID, 39 mm OD Product Code: H3-82239. Intended for u recall (Z-1967-2009)Omni Life Science2009-09-10
Apex Hip System Bipolar Head, 22.225mm ID, 40 mm OD Product Code: H3-82240. Intended for u recall (Z-1968-2009)Omni Life Science2009-09-10
Apex Hip System Bipolar Head, 22.225mm ID, 41 mm OD Product Code: H3-82241. Intended for u recall (Z-1969-2009)Omni Life Science2009-09-10
Apex Hip System Bipolar Head, 22.225mm ID, 42 mm OD Product Code: H3-82242. Intended for u recall (Z-1970-2009)Omni Life Science2009-09-10
Apex Hip System Bipolar Head, 22.225mm ID, 43 mm OD Product Code: H3-82243. Intended for u recall (Z-1971-2009)Omni Life Science2009-09-10
Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 44 mm OD Product Code: H3-82844. Inte recall (Z-1972-2009)Omni Life Science2009-09-10
Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 45 mm OD Product Code: H3-82845. Inte recall (Z-1973-2009)Omni Life Science2009-09-10
Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 46 mm OD Product Code: H3-82846. Inte recall (Z-1974-2009)Omni Life Science2009-09-10
Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 47 mm OD Product Code: H3-82847. Inte recall (Z-1975-2009)Omni Life Science2009-09-10
Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 48 mm OD Product Code: H3-82848. Inte recall (Z-1976-2009)Omni Life Science2009-09-10
Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 49 mm OD Product Code: H3-82849. Inte recall (Z-1977-2009)Omni Life Science2009-09-10
Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 50 mm OD Product Code: H3-82850. Inte recall (Z-1978-2009)Omni Life Science2009-09-10
Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 51 mm OD Product Code: H3-82851. Inte recall (Z-1979-2009)Omni Life Science2009-09-10
Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 52 mm OD Product Code: H3-82852. Inte recall (Z-1980-2009)Omni Life Science2009-09-10
Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 53 mm OD Product Code: H3-82853. Inte recall (Z-1981-2009)Omni Life Science2009-09-10
Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 54 mm OD Product Code: H3-82854. Inte recall (Z-1982-2009)Omni Life Science2009-09-10
Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 55 mm OD Product Code: H3-82855. Inte recall (Z-1983-2009)Omni Life Science2009-09-10
Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 56 mm OD Product Code: H3-82856. Inte recall (Z-1984-2009)Omni Life Science2009-09-10
Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 57 mm OD Product Code: H3-82857. Inte recall (Z-1985-2009)Omni Life Science2009-09-10
Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 58 mm OD Product Code: H3-82858. Inte recall (Z-1986-2009)Omni Life Science2009-09-10
Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 59 mm OD Product Code: H3-82859. Inte recall (Z-1987-2009)Omni Life Science2009-09-10
Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 60 mm OD Product Code: H3-82860. Inte recall (Z-1988-2009)Omni Life Science2009-09-10